generic hepatitis c drugs

Are Generics Worse than Brands?

 Are Generics Worse than Brands?

The generic versions of the medication always create a lot of debates and rumors. The supporters claim that generics allow treatment access to a larger group of people. Their opponents put the use of generics somewhere next to Internet piracy and watching the movies online. They also throw the arguments like “generics are ineffective” and “generic drugs stalls the R&D”.
Here we tried to clarify the situation by putting together some myths and facts about generic drugs.

generics hepatitis c drugs

Generics Mythbusters

Generics are not the same as the branded drug?

Plausible

According to the FDA, “a generic drug is identical – or bioequivalent – to a brand

name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.” Generics have the same function of the brand product, but come at a lower cost. So yes, generics are the same as the branded drugs, but the price and packaging is not the same.

Generics are not as effective as the branded formulation

Busted

In order to gain FDA approval, generic manufacturers must prove that their product:

  • contains the same active ingredients as the brand,
  • is identical in strength, dosage form, and route of administration,
  • have the same indication as the brand,
  • is bioequivalent to the brand,
  • meets the same batch requirements for identity, strength, purity, and quality as the brand,
  • is manufactured under the same standards of good manufacturing practice regulations that the FDA requires for brand products.

It means that the efficiency of the generics is the same as the efficiency of the brands.

FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs.

Generics don’t look the same as branded drugs.

Confirmed.

Quite often some existing patents and trademark regulations prevent generic manufacturers from developing a product that looks identical to the brand, be it the size, shape or color. While there can be similarities in appearance between the brand and the generic, the generic medicine cannot match the brand exactly. Even though they may look different, generic products maintain the same safety and efficacy as the brand.

Generics don’t require the same level of animal studies as the branded drugs.

Confirmed.

In case of generics, it is not necessary to repeat the discovery of the formulation or pre-clinical and clinical studies. Also, marketing investment is much less: generic firms generally don’t do advertising and promotion.

This is often the reason why generic drugs are less expensive.

Would the fact that the animal and human studies weren’t done mean that generics are dangerous? Not really, because the bioequivalency requirement proves that the drug is exactly the same (same chemical formula, molecule, etc.) as the one that was already tested. Since the substance is exactly the same, the effect it produces on animals and in clinical studies would have been exactly the same.

The review process of brands and generics are summed up in the table below.

Brand Name Drug vs. Generic Drug Review Process

Brand Name Requirements Generic Requirements
1. Chemistry 1. Chemistry
2. Manufacturing 2. Manufacturing
3. Testing 3. Testing
4. Labeling 4. Labeling
5. Inspections 5. Inspections
6. Animal Studies 6. Bioequivalence
7. Clinical Studies
8. Bioavailability

 

If the generics are not FDA approved, they are either not safe or not effective.

Busted.

FDA approval certifies that the generic is a quality medication, safe, effective and equivalent to the brand. However, a simple fact that the drug isn’t FDA approved doesn’t necessarily mean that it isn’t safe to use or that it is less effective. In reality, there are many generics produced outside of the US that are approved by the dedicated governing body of their country and are just as good as the brands.

Let’s look at the example of generics for new hepatitis C drugs: sofosbuvir and sofosbuvir – ledipasvir combo. For the patent reasons these generics won’t be FDA approved for a while, but would that mean that they are not safe or not effective?

According to European Association for the Study of the Liver and to the results of The International Liver Congress™ 2016 in Barcelona, Spain, the affordable hepatitis C generics are equivalent to branded formulations.

This means that the generics for hepatitis C treatment that are currently produced in India are just as safe and effective as the brands, but existing patent wouldn’t allow their production and distribution in the US.

The explanation is that new antivirals for hepatitis C treatment were discovered (and patented) only recently. So, despite the existence of generic drugs in India and all the efficiency of these formulations, it will take some 20 years for the generic hepatitis C drugs to hit the US market. (And until this time, the price of those drugs in the US, even if it will be gradually decreasing, is still likely to remain sky-high.)

Doctors Without Borders have many examples where generic drugs are used safely to help many people in poor countries to fight the diseases, but for patent reasons these generics can’t be FDA approved yet.

Do you like an idea of buying hepatitis C drugs for $1,000 instead of $85,000? Let your friends know! Share this page on Facebook!

Patents and FDA approval: how are these two related?

FDA claims that they approve a generic drug on the first day it legally can do so. At the same time, not every brand-name drug has a generic drug. How so?
The thing is, when new drugs are first invented, they are protected by intellectual property patents – for 20 years in most cases. The patent doesn’t allow anyone else but the inventor of the drug to make and sell it.
Other drug companies can start producing a generic version of the drug only once the patent expired. Only then the company can have this drug tested and submit it for FDA approval. Once the approval is granted, the drug can be legally distributed in the US.
This process is graphically explained in the chart below.

generics drugs approval process

Generics vs Brands: Summing it up

In the US about 70% of the prescription drugs sold today are generic drugs. Generics allow significant cost-saving options in developed countries, and are the only option for the majority of the 3rd world.

The generic industry is very important for providing low cost medicines in the developing world, especially for the regions like Sub-Saharan Africa, where the burden of HIV, HCV and TB is particularly high. In the last decades, patents and intellectual property restrictions are posing more and more problems for developing nations.

The situation gets worse when the concept of generic drugs is misunderstood. Sometimes big pharmaceutical companies are to blame for the rumors about generics.

It is important that the customers understand the difference between the brands and the generics and buy generic drugs to support the generic manufacturers when it is possible.

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hepatitis C treatment with generics in India

Hepatitis C treatment in India for less than $1000

Hepatitis C Treatment Costs Less Than $1000

With Indian Generics, Full Hepatitis C Treatment Course Costs Less Than Just One Brand-Name Pill in the US. But Does It Work?

For the last three months the rumors about cheap generic drugs for hepatitis C treatment are spreading all over the net. The forums and blogs explode with the comments promoting Indian generics in all possible ways: we hear about Australian doctors shipping hepatitis C drugs from India and about the programs that you can enroll in to get the generics delivered to your door. Some blogs who had previously gained the reputation of proven HCV advocates suddenly get attacked by Gilead for the attempt of smuggling Ledisof from India, and all of a sudden there are more “online pharmacies” than the stars in the sky.

With all this controversial info, it is very difficult to know what to believe. Common sense tells us that a complete hepatitis C treatment course, even with generics, can’t cost under $1000 – especially when in the US the same drug comes at $1000 a pill. In this post we tried to compile the information about the Indian companies producing the generics. We also collected several myths about generic drugs and researched as much as possible about them, trying to unveil the truth.hepatitis C treatment with generics in India

Why would Gilead allow someone else to produce hepatitis C treatment for 1% of the price?

To respond to criticism from HCV advocates and numerous NGO’s about Gilead’s aggressive pricing strategy, the Big Pharma signed voluntarily license agreements with several generic manufacturers in India. An empathy for poor people of developing world or a smart strategic decision – whatever it was, this Big Pharma’s move had some serious consequences that we discussed here.

Who is producing generic hepatitis C treatment?

The licensing agreements signed in India allow generic manufacturers to make and sell copies of the expensive drug at lower prices. Among the most reputed drug-makers producing affordable generics for hepatitis C treatment are Mylan, Natco Pharma, Zydus and Hetero.

What’s all the fuss about?

According to WHO’s latest estimations, over 170 million people are diagnosed with hepatitis C worldwide. The total number of hep-C-positive people is even higher, because due to the discreet nature of the disease many patients are not diagnosed until a much later stage. Hepatitis C kills about 350,000 people a year.
The drugs in question, sofosbuvir (sold under a brand name Sovaldi®), and a combination of sofosbuvir and ledipasvir (brand name Harvoni ®) are the hepatitis C latest-generation direct-action antivirals, and are currently considered as the most effective therapy for hepatitis C. The steep price of the medication makes the branded formula virtually inaccessible to the majority of the patients.

Mylan: affordable generics and specialty pharmaceuticals manufacturer

Mylan, despite rumors, is not an Indian company, even if it holds a controlling interest in India-based pharmaceutical ingredients producer. Mylan N.V. is registered in the Netherlands and has the headquarters in the UK. Through its acquisitions (Matrix Laboratories Limited and Merck KGaS), Mylan became a second-largest generic and specialty pharmaceuticals company in the world.
For instance, in the US alone the company has five different locations. In India and China Mylan operates nine API and intermediate manufacturing facilities. Mylan name is well known in Europe, but only few know that Arcana Arzneimittel GmbH, Generics Pharma Hellas, Gerard Laboratories, Qualimed, Somerset Pharmaceuticals, Agila Specialties and Docpharma are actually Mylan companies as well.
With its numerous subsidiaries, over 30,000 employees, and a presence in 150 countries, Mylan has a global manufacturing output of more than 45 billion doses.

Among Mylan’s products for hepatitis C treatment are MyHep® (sofosbuvir 400 mg), MyHep-LVIR® (sofosbuvir 400 mg and ledipasvir 90 mg) and MyDacla® (daclatasvir 60 mg).

Hetero:  hepatitis C treatment, antivirals and cancer drugs

Hetero Drugs Limited is an Indian pharmaceutical company founded in 1993 in Hyderabad by Dr. B. Partha Saradhi Reddy Phd., a scientist and chemistry expert. Nowadays, with over 15,000 employees, revenues over a billion and the marketing presence in over 100 countries, Hetero Drugs is one of the major players of pharmaceutical industry. The company is famous for its presence on generledifos sofosbuvir ledipasvir generics for hepatitis Cic drugs market, but also for its antiviral and cancer drugs. Just yesterday, Hetero announced the launch of new colorectal cancer drug.
Hetero Drugs has also a strong presence in API market and its manufacturing plants have FDA and WHO approvals. It is also a parent company of Hetero group that includes Hetero Labs, Hetero Research Foundation, Symed Labs Limited, Cirex Laboratories, Genx Laboratories, Camber Pharma, and many others.

Hetero’s sofosbuvir is sold under a brand name Sofovir®. The company was also the first one in India to receive a DCGI approval to start the production of hepatitis C treatment for genotypes 1 and 4, distributed under the brand name Ledifos®.

 

 

Zydus Cadila: among top 10 U.S. generic companies

Cadila Healthcare is an innovative, global pharmaceutical company headquartered at Ahmedabad, in Western India. The company is the fifth largest pharmaceutical company in India and has nine nine pharmaceutical production facilities. Significant manufacturer of antivirals for hepatitis C treatment and generic drugs in general , Cadila also produces a wide range of diagnostics products, as well as herbal, skin care and other OTC products.
The U.S. division of Cadila Healthcare called Zydus Pharmaceuticals Inc. is located in Pennington, NJ. For the past 10 years annually Zydus was recognized as one of the fastest growing pharmaceutical companies in the U.S. The company is also in the top 10 U.S. generic companies by the total number of prescriptions dispensed.
Zydus Cadila manufactures over 50% of their active pharmaceutical ingredients (API), and even produces their own bottles. The company claims that this allows them to maintain the excellent supply record, in line with their focus on providing outstanding customer service and high-quality, affordable generics.

affordable generics hepatitis C India

SoviHep ®, a Zydus’s brand of sofosbuvir, is marketed by the the specialty division of the group, Zydus Heptiza.

Natco: the fastest growing pharmaceutical company?

Natco Pharma Limited was incorporated in Hyderabad, India, 35 years ago. Starting operations as a single unit with only 20 employees, today the company has over 3,200 employees spread between five manufacturing facilities. Constantly ranked among the fastest-growing pharmaceutical companies in India, Natco is also recognized for its innovation in Pharmaceutical R&D.

Starting from 2015, Natco produces a full range of products for hepatitis C treatment, including HEPCINAT® (sofosbuvir), HEPCINAT-LP® (sofosbuvir – ledipasvir) and NATDAC® (daclatasvir).

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Five most common hepatitis C questions

Five most common hepatitis C questions

Hepatitis C questions that you always wanted – but never dared – to ask

hepatitis C questions

Posing a hepatitis C question to a doctor is the best way to learn, but if it’s your friend or a family member who is suffering from hepatitis, you might not have an occasion to talk to a doctor. We figured out the answers to some hepatitis C questions for you, so that you won’t feel dumb or poorly informed if the conversation starts. (If you are reading this page, it probably means that hepatitis C is not an empty word for you – and THE conversation will start sooner or later).

Hepatitis C question #1: Is it contagious?

This is one of the most common hepatitis C questions.

Yes, it is contagious. But mostly only through blood.

HCV is transmitted primarily through large or repeated percutaneous exposures to infectious blood. Center for Disease Control and Prevention

In other words, you need to be exposed to contaminated blood through a cut in the skin in order to catch the virus. Such “exposure” includes:

  • Injection drug use (the most common way of transmission in the US today),
  • Needlestick injuries (in the labs or hospitals, for example),
  • Surgeries, dentist intervention, blood transfusions or organs transplants (mostly before 1992, when the routine screening was introduced in the US and majority of the developed countries).

Sometimes, much more infrequently, hepatitis C can also be transmitted by:

  • An HCV-infected mother giving birth to a child,
  • Sharing blood-contaminated personal items (razors, toothbrushes, nail clippers),
  • Having sex with HCV-infected person (especially men having sex with men, and especially in co-infection with HIV),
  • Other invasive procedures that were not done according to sanitary regulations (piercings, tattoos, injections in the context of hepatitis C outbreaks).

However, these later transmission ways are very inefficient means of transmission, meaning that the contamination chances are very low. The chances increase in case of repeated risky behavior – such as constant sharing the razor with infected person.

Hepatitis C virus can survive outside of human body (inside the syringe or on the razor, for instance) for several weeks!

Hepatitis C is much less contagious than hepatitis B; luckily, a vaccine exists for hepatitis B. Also, the risk of transmitting hepatitis C increases with the viral load – a number of copies of the virus in the infected person’s blood – especially when it comes to mother-child contamination during labor.

Hepatitis C question #2: Is there a hepatitis C vaccine?

This is another very common hepatitis C question. The answer is no, there is no vaccine against hepatitis C. The main problem is that the virus undergoes the transformations in the human body, so the human immune system doesn’t react to the virus straight away as it would with some other diseases. For the same reason, people who had hepatitis C and then were cured – either clearing the virus spontaneously or by following a hepatitis C treatment – are not immune and can catch the virus again if they are exposed to it.

Research into the development of a vaccine is ongoing, but nothing really promising yet.

It is highly recommended that people infected with hepatitis C get vaccinated against hepatitis B, because the harm caused to the liver from both simultaneous infections is increased.

Hepatitis C question #3: Can I give it to my family and friends?

Technically the answer is yes, but this does not happen very often. In the most cases when it happens it is through blood exposure with an infected friend or family member.

If you dispose of sanitary napkins correctly, cover the bleeding sores and don’t share razors, toothbrushes, nail clippers – or needles and syringes – with friends, it is highly unlikely that they get a virus from you.

Hepatitis C is not transmitted by sharing food and kitchen utensils, such as glasses and spoons. It is also not transmitted by hugging, kissing, sneezing, coughing or shaking hands.

If you discover that you have hepatitis C, it is not really necessary for all your family to get tested – unless there were some specific risks. However, if you think that you might have had hepatitis C while being pregnant, it is highly recommended that your child gets tested.

Hepatitis C question #4: What about my sexual partners?

Scientific studies show that even though sexual transmission is technically possible, the chances are very low. HCV transmission has not been demonstrated in heterosexual couples monitored over time, according to CDC. It means that condom use in stable monogamous relationship between a man and a woman is not required.

We talk about stable relationship, because to convey the study, the couple has to be monitored over the time – and therefore, there can only be scientific evidence for the stable couples. Again, we talk about monogamous relationship, because if either of the partners in the study had other partners, he or she could have caught the HCV from them – so again, carrying out the study and getting valid results would be impossible in this case.

Obviously, when it comes to spontaneous intercourse with a random partner, people infected with hepatitis C should protect their partners – and themselves, for this matter – from hepatitis C, hepatitis B, HIV and other diseases by wearing a condom. It is especially important to wear a condom when it comes to the intercourse between HCV-infected men, and especially if they are co-infected with HIV. The risk of sexual transmission for this case is much higher.

Hepatitis C question #5: What are the symptoms of HCV?

In many cases the chronic hepatitis C infection goes without symptoms, and this is why so often it remains unnoticed. Over the time the infection leads to mild to severe liver disease, including liver cirrhosis and cancer.

The lack of symptoms in the early stage of chronic disease is the reason why many people are identified as HCV-positive during routine blood test (when their liver enzyme levels such as ALT, AST are elevated) or during blood donation.

Nevertheless, chronic hepatitis infection is always preceded by the acute one, which in some cases is easier to spot. If a person is to develop hepatitis C symptoms, he or she will usually have them between 4 and 12 weeks following the exposure.

Bonus question: Who should be tested for HCV infection?

The testing is recommended for anyone who has increased risk of having hepatitis C. This includes:

  • People born before 1965,
  • People who received blood transfusions, organ transplants or clotting factor concentrates, especially before 90’s,
  • Injection drug users, even if they only used it once, and even if it was long time ago,
  • Patients who had long-term hemodialysis treatment,
  • People with known HCV exposure, such as nurses involved into needlestick incident while working with HCV-positive blood,
  • People who show the symptoms of liver disease, such as jaundice or abnormal liver enzymes test,
  • Children born to HCV-positive mothers.

In the latter case, to avoid a false positive test triggered by mother’s antibodies the child shouldn’t be tested until the age of 18 months.

Unlike hepatitis B, hepatitis C is less contagious and the transmission chance during the labor is low. Also, there are no vaccine and no preventive measures that could be taken to avoid this transmission. So, despite what is commonly believed – and this is another commonly asked hepatitis C question – routine HCV testing of pregnant women is not necessary (unless they are in one of the high-risk groups mentioned above).

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India grants GILEAD a patent for sofosbuvir – Page3

India grants GILEAD a patent for sofosbuvir

Patent for sofosbuvir, hepatitis C $1000-per-pill treatment

 

The patent for sofosbuvir granted to Gilead this week raises many concerns. It gives Gilead an unlimited control over their licensed manufacturers. Rumors spread saying that the medication purchase will be restricted to Indian residents and that the amount of the medication one can buy will be limited. Apparently, only one bottle will be sold at once, and the next one could be obtained only four weeks later, and only if the empty bottle is returned. The bar-code system could also be implemented to improve the control over the medication purchase and use.

For the moment these are only rumors. Even if these measures are actually taken, the practical implementation will take time and in some rural areas of India will be simply impossible.

Patent for sofosbuvir: the end of medical tourism in India?

patent for sofosbuvir no more generics in india

Sofosbuvir-based Indian generics (Ledifos, MyHep and others) are already sold only with hepatologist’s prescription. Their price – 20,000 rupees per bottle – seems extremely attractive to Americans and Europeans, but is sky-high for an average Indian. It is hard to image the bar-code scanning system in some areas that don’t even have electricity.

If these restrictive measures are taken, not only the new hepatitis C treatment will be out of most Indian’s reach, but it will also cut down drastically medical tourism in India.

Other countries

Sofosbuvir patents have been rejected already in China, Egypt and Ukraine. It is probably not a simple coincidence that Gilead granted two licenses to the manufacturers in Egypt.

The patent oppositions have been filed in several other countries, including Argentina, Brazil, Russia and Thailand.

What’s the fuss about? Hepatitis C Facts

The liver-destroying virus of hepatitis C affects about 180 million people worldwide. It is primarily transmitted through blood-to-blood contact, even though sexual transmission is possible in high-risk groups. In 80% of the cases, the undetected and untreated hepatitis C infection becomes chronic and can thus lead to liver stiffness, liver cirrhosis, liver failure and liver cancer.

Hepatitis C is considered to be one of the most common causes of death from infectious disease, according to the study of Center for Disease Control and Prevention in the US. In 2013, the annual mortality from hepatitis C exceeded the total combined number of deaths from 60 other infectious diseases, including HIV, pneumococcal disease, and tuberculosis. Worse even, this data is based on death certificates which often state the immediate cause and overlook the root cause – hepatitis C – so the actual numbers of hepatitis C deaths might actually be even higher.

Sofosbuvir is a highly effective substance with minimal side affects. It is listed on the World Health Organisation Essential Medicines List, making it a high priority drug for hepatitis C treatment. Sofosbuvir-based drugs Sovaldi™ and Harvoni™ are FDA-approved in the US. The patent for sofosbuvir and its prodrugs belongs to Gilead Sciences.

 

 

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India grants GILEAD a patent for sofosbuvir – page2

India grants GILEAD a patent for sofosbuvir

Patent for sofosbuvir, hepatitis C $1000-per-pill treatment: the end of medical tourism?

 

patent for sofosbuvir brings gilead moneyPatents are meant to protect the companies from generic competition, allowing them to get the return on their R&D investment and to use the profit to develop new formulations. Unfortunately, without competition – and that’s the case with a patent for sofosbuvir – the pharmaceutical companies can set the unprecedented prices.

In 2014, Gilead earned $10.3 billion with Sovaldi™alone, and $25 billion in total – and roughly a half of this figure in 2013. Sofosbuvir was initially developed by a small company Pharmasset, which was acquired by Gilead in 2011 for $11.2 billion. Therefore, all R&D investment was paid off long time ago.

So  today, who needs protection more  – Gilead from the competition or hepatitis C patients from atrocious pricing strategies?

Patent for sofosbuvir granted, and now what?

A day after the patent was granted on new hepatitis C treatment, patient groups and companies are already planning to challenge it. Many health advocates claim that sofosbuvir does not deserve a patent and prepare to launch an appeal to the Patent Office’s decision.

“Gilead’s sofosbuvir was developed with previously published techniques that have been used repeatedly in other antiviral drugs and therefore does not deserve a patent. In fact, Gilead’s unjustified patents for sofosbuvir have already been rejected by China, Ukraine and Egypt. With pressure growing from US trade regime and from Gilead’s manipulative licensing deals, the patent office’s latest decision ignores the truth about sofosbuvir and fails to uphold the standards of Indian patent law. I-MAK and the Delhi Network of Positive People (DNP+) will appeal the decision to ensure the Indian patent system stays accountable to the integrity of the law and to the public’s health.”  Tahir Amin, co-director of the Initiative for Medicines, Access & Knowledge

(more…)

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India grants GILEAD a patent for sofosbuvir – page1

India grants GILEAD a patent for sofosbuvir

Patent for sofosbuvir, hepatitis C $1000-per-pill treatment: the end of medical tourism?

 

People before profit patent for sofosbuvir

Gilead Sciences was seeking a patent for sofosbuvir since 2014, and had already seen their application rejected by India’s patent office in January 2015. After the rejection appeal, India was forced to reverse the course. The patent for sofosbuvir, the direct-action antiviral treatment for hepatitis C and the active component of the scandalously priced Sovaldi™ was now granted to Gilead.

The Indian Patent Office of New Delhi claimed this Monday that sofosbuvir was “novel” and “inventive”. Surprisingly, just 16 months ago the same patent office said the drug represented only minor changes to a previous formulation, and thus lacked the patent requirements.

Gilead announced that this decision would have no impact on availability of the compound, which is already licensed to several generic manufacturers in India. Despite Gilead’s statement, there are rising concerns that this move can stop affordable copies of antiviral treatment for hepatitis C or significantly limit its availability.

If the patent was not granted, the non-license companies could have entered the hepatitis C market, forcing the price to go down. Most importantly, these companies, not limited by license agreements, could have supplied to the “restricted” middle-income countries.

 

Patent for sofosbuvir, hepatitis C $1000-per-pill treatment: the end of generic hepatitis C treatment?

license agreement

Licensing agreements between Gilead and seven Indian companies were signed as early as September 2014. The number of the licensees has now increased to 13. Eight of these companies (Hetero, Natco, Mylan and Cipla, among others) have launched sales in India and other licensed territories. The license allows the distribution of new hepatitis C drug in 101 developing countries. The goal of this voluntary licensing program and “partnership” with Indian manufacturers, according to Gilead, is to enable access to antiviral treatment for hepatitis C for as many people as possible, as quickly as possible.

The major complication is that these licensed territories are so-called “resource-challenged countries”; the middle and high-income countries are excluded from the scope. This leaves approximately 50 million of people suffering from hepatitis C without access to the affordable treatment. With the price that Gilead is charging for its original, branded drug, it is out of question that the “middle-income” patients can afford the treatment.

Sovaldi™ was launched in the US at a list price of $28,000 for a 28-tablet bottle, or $1,000 a pill.

The generic version is sold in India at about $14 per pill.

The cost of the hepatitis C 12-week treatment course is around $84,000 in US, $50,000 in France and $1200 in India.

 

 

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New hepatitis C treatment costs only $1000

New hepatitis C treatment costs only $1000

Indian generics of new hepatitis C treatment cost a fraction of the original drug, but can only be sold in “low-income countries”

new hepatitis c treatment cost

On January 13, 2015, Indian Patent Office has taken a decision to reject Gilead’s application for sofosbuvir patent. Shortly after, Gilead started putting pressure on India, including the Indian Department of Industrial Policy overseeing the Patent’s Office, trying to reverse this decision. One of the Gilead’s arguments is that regardless of the patent decision, accessible sofosbuvir will still be available in India and other developing countries.

 

In September 2014 Big Pharma signed voluntary license agreements – no doubt, aimed at saving their patent rights – with seven India-based generic manufacturers: Zydus Cadila, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy, Sequent Scientific and Strides Arcolab. These agreements are meant to broaden access to innovative hepatitis C drugs, sofosbuvir (known in the US under the trademark Sovaldi™) and ledipasvir (which later became one of the active components of Harvoni™), by enabling the production of their generic versions for some countries, defined by Gilead.

This license, however, was widely criticized by many experts and HCV advocates. Questions arouse whether Gilead will really allow access to the medication – or this is just a trick to avoid open generic competition that could disturb the market and bring down the new hepatitis C treatment cost.

“…Gilead’s licensing terms fall far short of ensuring widespread affordable access to these new drugs in middle-income countries, where over 70 % of people with hepatitis C live today.”  Médecins Sans Frontières

(more…)

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New treatment for hepatitis C from India

New treatment for hepatitis C from India

Generic sofosbuvir and ledipasvir – used in a combination as a new treatment for hepatitis C – will cost 1/90 of their US price

Despite its amazing efficiency, little side effects and short treatment course, the new direct-action antiviral, sofosbuvir (used together with ribavirin, daclatasvir or ledipasvir as a new treatment for hepatitis C), is only prescribed to a tiny fraction of patients. And no wonder! At $1,000 per pill, it is the drug that the majority of the developed world simply can’t afford.

Gilead, the owner of sofosbuvir patent in the US, has been widely criticized for its outrageous pricing strategy. In India, however, their approach is very different. In September 2014, Big Pharma signed voluntarily licensing agreements with seven Indian generic drug manufacturers. According to these agreements, generic version of sofosbuvir can now be produced for sale in India and 90 other developing and middle-income countries – with a much more modest price tag.

new treatment for hepatitis C produced in India

The licensees are free to set their own price. While Gilead planned to sell original Sovaldi™ in India for $900, generic manufacturers will probably sell it for even less. Even at this discounted price the drug still won’t be affordable to Indians, the critics say, pointing out that GDP per capita in India is only $1480.

India GDP and Sovaldi price
Based on Wikipedia data. Currency: Indian Rupees.

The manufacturing costs of 12-weeks sofosbuvir treatment are less than $150, according to expert estimation.

While the new hepatitis C drug remains too expensive for Americans in the US, for Europeans in Europe and for Indians in India, Indian generics will be perfectly affordable for Western population. Even keeping in mind the travel costs, hep C-related medical tourism in India is likely to flourish.

Some already propose innovative – and often daring – solutions to import new treatment for hepatitis C to their home country (read here).

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New hepatitis C treatment in India: People Before Profit or Smart Strategic Decision?

New hepatitis C treatment, sofosbuvir in India: People Before Profit or Smart Strategic Decision?

New hepatitis C treatment is novel and creative, but not novel and creative enough

new hepatitis c treatment in India

 

On 13 January 2015 India has rejected Gilead’s patent application for the new hepatitis C treatment, sofosbuvir. HCV advocates all over the world applauded to this brave decision, but little do we know about the reasons behind it.

India’s patent system: a reason for thriving pharmaceutical industry

India’s patent system is quite controversial, and particularly in what concerns pharmaceutical industry. Until 2005, only “process patents” existed according to India’s Patents Act. This basically meant that pharmaceutical companies could recreate another company’s product by simply making changes to production process. Process patent system was the reason why Indian pharmaceutical industry prospered and became one of the world’s largest.

India has made it to the list of the countries that “present the most significant concerns regarding insufficient [intellectual property rights] protection or enforcement”, according to United States Trade Representative.

The current India’s patent system was put in place in 2005 and allows the companies patenting the substance and not just the process of producing it. However, to avoid all the cheating when the companies make minor changes in order to refresh their patent, a provision was put in place (so-called section 3(d)):

“the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant [are not inventions within the meaning of this act].”

Section 3(d) and the therapeutic efficacy requirement was cited in the patent office’s decision to reject Gilead’s patent application.

New hepatitis C treatment is novel and creative, but creativity is not the point

The decision agrees that the changes described in the application make sofosbuvir “novel and inventive.” However, “a molecule with minor changes in addition to the novelty must show significantly enhanced therapeutic efficacy as compared to the nearest prior art molecule which is structurally and functionally close,” decision says. This “closest prior art,” in case of sofosbuvir, is a compound D1 (patent WO2001/92282).

According to the Patent’s Office Decision, the application does not have sufficient data to prove this required therapeutic efficacy improvement. Attention though, it might only mean that Gilead needs to acquire more data before filing another patent application, and that the battle over the patent for the miraculously effective new hepatitis C treatment isn’t final yet.

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Big Pharma loses a battle for sofosbuvir patent

Big Pharma loses a battle for sofosbuvir patent…

new hepatitis C treatment in India

New hepatitis C treatment drug, sofosbuvir, was already patented in numerous countries, including the United States. On 13 January 2015, the Indian Patent Office made a striking decision that can become one of the most prominent ones in modern medical history. A patent application for the new direct-action antiviral drug sofosbuvir – used in a combination as the new hepatitis C treatment –  was rejected.

The main reason for rejection is that sofosbuvir lacks novelty or inventive manufacturing steps required under the Indian Patents Act.

How is it possible? Is this decision final?

Explanations here.

New hepatitis C treatment at affordable price? Myth or reality?

Final or not, this decision means that new hepatitis C treatment will be soon available – and at price that doesn’t bite, too! – to hepatitis C sufferers in India and poor neighboring countries. Some patients in middle- and high-income countries, where access to treatment is restricted, might also benefit from new affordable hepatitis C treatment in India.

Medical tourism always played an important role in India’s economy. For the last twenty years India has been a pharmacy of the third world’s countries, with its pharmaceutical industry ranking the 3rd in terms of volume and 14th in terms of value.

Big Pharma loses a patent… and signs licensing agreements to produce new hepatitis C treatment in India

Gilead, the pharmaceutical company applying for sofosbuvir patent, seems to be prepared for this turn of events. Three months ago, on 15 September 2014, it already signed voluntary license deals with seven Indian generic manufacturers. These deals will allow boosting the production in India by transferring Gilead’s manufacturing process to the licensees in exchange for 7% royalty payment. The generic manufacturers are free to set their own pricing strategy for Indian market. The launch of generic versions of sofosbuvir is expected by the third quarter of 2015.

Gilead was already accused for extortionate prices of new medicines for hepatitis C in the US. At $1,000 per pill, it is highly unlikely that the original version of Sovaldi™ can make it to the Indian market. This smart move with licensed generics will allow Big Pharma getting their share from new hepatitis C treatment in India and securing their revenue coming from the third world – the revenue that otherwise would not have existed at all.

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