WHO to Bring Affordable Biosimilar Drugs to Low- and Middle-Income Countries

The World Health Organization (WHO) is slated to launch a pilot project to evaluate biosimilar agents of expensive anti-cancer drugs to make the treatments more accessible in low- and middle-income countries.

Starting this fall, WHO will invite pharmaceutical manufacturers to submit applications for prequalification of biosimilar versions of two cancer drugs already on its essential medicines list:  rituximab and trastuzumab. With its prequalification program, WHO routinely investigates drug quality to ensure that poorer countries are receiving medications of acceptable quality.

If the submitted biosimilars pass the prequalification, the drugs will be listed as eligible for procurement by WHO and can be purchased for distribution in low- and middle-income countries.

WHO also plans to re-evaluate its 2009 guidelines on biosimilar agents to ensure the process is up-to-date and in keeping with recent evidence.

The use of biosimilar agents is expected to rise in the coming years as prescription-drug prices continue to mount and as patents on original drugs expire.  Because the source for these drugs is biologic and the product may change during manufacture, it is difficult to compare a biosimilar to its original, WHO noted in a news release announcing the program. “For that reason, WHO must accompany global policies on expanding access to biosimilars with rigorous guidance on the way these medicines are quality-assured before they enter markets.”

Source: World Health Organization press release, May 4, 2017; Reuters, May 4, 2017.