WHO prequalifies first generic hepatitis C drug

Generics/General | Posted 18/08/2017 post-comment0 Post your comment

The World Health Organization (WHO) has prequalified the first generic drug to treat hepatitis C. The antiviral agent sofosbuvir will be manufactured at a lower cost by Mylan.

Hepatitis C Virus V14A31

Hepatitis C infections affect the liver and can in some cases lead to liver disease and cirrhosis. Unlike hepatitis B, there is no vaccine to protect against hepatitis C, although chronic infections can generally be cured using antiviral medications, such as sofosbuvir.

New medicines like these have a high cure rate and limited side effects. However, the cost of these treatments is a major barrier to access and as a result the disease still kills an estimated 700,000 people each year and remains the leading cause for liver transplant.

To improve access to treatment, WHO prequalified the first generic version of sofosbuvir at the end of March 2017. The news follows several campaigns for hepatitis C generics from developing countries [1]. Prequalification assures the quality, safety and effectiveness of priority medicines bought by international procurers for low-income countries.

Sofosbuvir is taken by mouth and has cure rates of up to 97%. It was approved for use in the US four years ago and is on the WHO’s List of Essential Medicines, but a 12-week course costs around US$84,000 in the US in 2016. ‘Direct-acting antiviral medicines such as sofosbuvir are highly effective for treating and curing chronic hepatitis C infection. But, at best, 1 out of 10 people in need had access to these medicines in 2015,’ said Gottfried Hirnschall, Director of WHO’s Global Hepatitis Programme.

The generic version (sofosbuvir, 400 mg tablets) will be produced in India by Mylan Laboratories, which previously produced generic versions of the hepatitis C antiviral daclatasvir [2].

The drug will be produced at a lower cost (US$260 for a three-month treatment), enabling the UN and financing agencies such as Unitaid to access it. Dr Suzanne Hill, Director of WHO’s Essential Medicines and Health Products, said this is a major breakthrough: ‘The first WHO-prequalified generic of this product will give large procurers and countries the assurance of quality for an affordable product.’

Through strategies such as sublicensing agreements and generics competition, several low-income countries have already made good progress in reducing the cost of hepatitis C antivirals. For example, generics competition has reduced prices in Egypt from US$900 in 2015 to less than US$200 in 2016 (for a three-month course). WHO’s prequalification will provide an extra guarantee of quality and safety to those countries already procuring generic versions of sofosbuvir, including Cambodia, Indonesia, Vietnam and several parts of Africa.

WHO also recently prequalified the first HIV self-test in an effort to improve diagnosis and treatment rates. The test is manufactured by OraSure Technologies Inc and uses saliva to provide a result in less than half an hour. 

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1. GaBI Online - Generics and Biosimilars Initiative. India and Argentina call for  hepatitis C generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 18]. Available from: www.gabionline.net/Policies-Legislation/India-and-Argentina-call-for-hepatitis-C-generics
2. GaBI Online - Generics and Biosimilars Initiative. Mylan to make generic hepatitis drug under MPP sublicence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 18]. Available from: www.gabionline.net/Generics/News/Mylan-to-make-generic-hepatitis-drug-under-MPP-sublicence

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Source: World Health Organization

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