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?


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


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.


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.


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.


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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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


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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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