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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