Biosimilars Council Statement Regarding the World Health Organization’s Biosimilar Naming Proposal
Contact: Steve Arnoff 202.249.7113
WASHINGTON, DC (Feb. 11, 2016) -
Dr. Bert Liang, M.D., PhD, M.B.A.,CEO of Pfenex, Inc., Chair, Biosimilars Council:
“As advocates for policies that support patient access to biosimilars, the Biosimilars Council, a division of the Generic Pharmaceutical Association, is disappointed in the World Health Organization’s (WHO’s) final proposal on the Biological Qualifier (BQ), which could be a barrier to competition from these new versions of critical medicines. The system proposed by the WHO would assign a random code to the International Nonproprietary Name (INN) for biological substances. This proposal from the WHO is similar (although not exact) to the Food and Drug Administration (FDA) current guidance on the naming of biosimilars, as it is a nonsensical qualifier allowing identification of one biosimilar or biologic from another. The WHO guidelines are optional for adoption by each regulatory body, so it is expected that, rather than adopting the BQ proposed by the WHO, the FDA will continue to review the public comments received in response to its latest issued draft guidance on naming before finalization.
Further to the point of naming, there exists no compelling rationale for added identifiers for biosimilar drugs; on the contrary, based on available estimations, this will likely stifle uptake and market growth in the U.S. and other countries. The INN was designed to identify an active compound, rather than create a base for a branded naming system. Both the WHO and FDA naming proposals adding unique qualifiers to the INN of biosimilars defeats this core purpose.
In even more compelling evidence, biosimilars are used safely and effectively in Europe – as they have been for a decade – with no issues tracking these approved biosimilar drugs using the brand name. In the U.S., we have additional systems to allow the tracking of pharmaceutical drugs, including the National Drug Code (NDC) and lot number, which can be effectively used for biosimilar drugs – eliminating the need for these artificial distinctions that stand to stifle competition and may misleadingly undermine physician and patient confidence in biosimilar drugs.”
About the Biosimilars Council
The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.