The resolution made at the 67th annual Geneva session of the WHA, the decision-making body of WHO (World Health Organisation), urges WHO member nations:
- to strengthen national regulation to meet public health needs for biosimilars,
- to encourage scientific expertise and develop “solid, scientifically-based regulatory frameworks” for access to affordable, safe medicines, and
- to ensure new regulations do not prevent access to quality, affordable biologics, including biosimilars.
It also asked the WHO Director-General Margaret Chan to promote cooperation and exchange of information between countries about biosimilars.
While the WHA recognised there are multiple barriers to access to biopharmaceuticals, it singled out their high cost as “affect[ing] the sustainability of health systems” as well as hampering individual patient use.
Biosimilars “could be more affordable and offer better access” for patients than their biopharmaceutical reference products, it said.
The WHA said its resolution was spurred by public health concerns surround access to essential medicines, especially for children and people in poverty. “Catastrophic out-of-pocket payments for health care” are discouraging people from seeking or continuing drug regimens, it said, and the human right to “the highest attainable standard of health” is becoming an “increasingly remote” goal.
Written medicines standards need updating in the light of advances in biologics, “in order to ensure the entry into the market of medicines that are affordable, safe, efficacious, of quality and accessible in a timely and adequate fashion,” read the resolution.
The resolution was supported by pharmaceutical bodies IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) and EGA (European Generics Association).
"The WHA resolution is important as it highlights that science-based regulatory standards for medicines are essential to ensure patient safety. National implementation of the resolution is critical to ensure patient access to biotherapeutic medicines, including biosimilars," Mario Ottiglio, IFPMA spokesman, told BioPharma-Reporter.com.
EGA Director General Adrian van den Hoven called the resolutions “important milestones” and said they would help strengthen regulatory systems, particularly in developing countries.
Suzette Kox, Director of the European Biosimilars EGA Sector Group, added that “despite the many national and international efforts and initiatives to strengthen worldwide regulatory capacity and to move towards international convergence of regulatory practices,” developing countries will need help establishing regulations for biologics, including biosimilars.
She proposed “twinning” projects, sending experts from more experienced national drug regulatory bodies abroad to assist less experienced authorities. The WHO could take on the role of facilitator for this project, she said.