WHO Calls for Improved, Science-based Regulations on Biosimilars

Patients worldwide need access to affordable biosimilars, the World Health Organizations’ World Health Assembly (WHA) says, but not at the expense of safety or science. In a resolution passed at the assembly’s 67th meeting in Geneva, the organization urges member nations to adjust national regulations to accommodate the growing demand for biosimilars – while simultaneously ensuring that regulations have a scientific basis and do not impede access to biologics. The resolution reflects widespread concern about the high price of biologics.

Global industry organizations, including the European Generics Association and the International Federation of Pharmaceutical Manufacturers and Associations, supported the move. IFPMA spokesman Mario Ottiglio echoed the WHA’s position that “science-based regulatory standards for medicines are essential to ensure patient safety.”

The WHA’s resolution stems from concerns that “excessive out-of-pocket payments” may deter patients from seeking or receiving the care they need. Acknowledging the need for “quality, safety and efficacy of pharmaceutical products through the regulatory processes of authorization, vigilance and monitoring,” the resolution calls for member nations to cooperate and exchange information that can improve regulatory structures. The WHA requests that member nations report their progress at the 69th assembly meeting in 2016.

The WHA resolution reflects the multifaceted debate over biosimilars – ongoing at the state, national and international levels. Both regulatory bodies and state legislatures are considering safety, access and the need for clarity between biosimilars and biologics through distinct naming conventions. Debate centers on cost as well as the need to maintain patients’ access to the treatments their doctors prescribe.

 

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