The World Health Organization is looking at extending its prequalification system for biosimilar drugs in a bid to accelerate their availability for people in low and middle-income countries.
Under the prequalification programme the WHO checks whether a medicine or vaccine is safe, effective and of sufficient quality, creating a list of essential drugs that governments and international procurement agencies can buy with confidence. First used for HIV therapies in 2001 the scheme has since been extended to cover a broad range of essential medicines.
In the latest move the WHO says it will focus on biosimilar medicines, starting with Roche’s widely-used cancer drugs MabThera/Rituxan (rituximab) and Herceptin (trastuzumab), and is inviting companies who have developed biosimilars of the two products to submit applications from September. It is also looking into the possibility of prequalifying insulin products.
“Innovator biotherapeutic products are often too expensive for many countries, so biosimilars are a good opportunity to expand access and support countries to regulate and use these medicines,” said Dr Marie-Paule Kieny, WHO assistant director general for health systems and innovation.
Many low and middle-income countries rely on WHO prequalification before buying medicines, and a benefit of WHO prequalification could be to increase competition and further reduce the price of medicines according to the agency, which said it also plans to “advocate for fairer prices for all biotherapeutics to ensure that these treatments can truly benefit public health”.
The move comes as biosimilars of Rituxan and Herceptin are starting to find their way onto the market. Earlier this year the EMA approved Celltrion/Mundipharma’s Truxima version of Rituxan, while other biosimilar copies of the drug have started to roll out in India, Latin America, and Russia, according to a report by the Generics and Biosimilars Initiative (GaBI).
Meanwhile in the US Mylan recently cut a deal with Roche, which should allow it to launch a biosimilar version of Herceptin in the US ahead of its claimed patent expiry in 2019. The biosimilar -developed by Mylan and partner Biocon – is already available in some emerging markets including India.
“Biosimilars could be game-changers for access to medicines for certain complex conditions,” said Suzanne Hill, WHO’s director of essential medicines and health products. “But they need to be regulated appropriately to ensure therapeutic value and patient safety.”