Please login to the form below

Not currently logged in

WHO pilots scheme to make biosimilars available to poorer countries

Plans to expand prequalification scheme to medicines such as Roche’s Rituxan and Herceptin


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."

Article by
Phil Taylor

5th May 2017

From: Regulatory



Featured jobs

Subscribe to our email news alerts


Add my company
EY Life Sciences

Our global reach Against a backdrop of regulatory, digital, financial and global transformation, Life Sciences companies are finding integration and...

Latest intelligence

Tools for the digital world
The next step for the pharma industry...
How Can We Make Payer Communications Really Sing?
With so many different influences at play in access decisions, how can we make sure we tap into what’s really driving payer decision-making. How do we go beyond the stated...
Harnessing the power of core elements to optimise market access
This article by John Spoors and Anton Abrahams focuses on optimising market access – the RJW and Solaris Health teams operate across all major markets, where the principles set out...