GPhA and its Biosimilars Council Applaud IGBA Call for WHO Biologic Qualifier Impact Assessment
Contact: Steve Arnoff 202.249.7113
WASHINGTON, DC (March 2, 2016) —
Statement by Chip Davis, President and CEO, GPhA:
“The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council applaud the International Generic and Biosimilar medicines Association (IGBA) for urging the World Health Organization (WHO) to conduct an international impact assessment of the voluntary biologic qualifier (BQ) proposal on biologic product access, quality and safety.
The Biosimilars Council does not support the addition of a random BQ assigned to the international nonproprietary name (INN) for biologics and shares the IGBA concern that WHO will need more time to properly assess the global implications of its BQ proposal.
The Council urges WHO to extend the timeline for this impact assessment in order to fully ascertain the range of concerns regarding implementation of the BQ approach including its questionable underlying rationale, uncertain retrospective application, and potential to limit competition and undermine provider confidence in safe and effective biosimilar products.
Tracking and safety concerns have long been addressed by the inclusion on the label of the brand name, company name, national drug code (NDC) and lot number, thus, eliminating the need for unnecessarily complicated and confusing suffixes or checksums — there is no compelling reason to add additional identifiers for biosimilar drugs.
Since the WHO guidelines are optional for each country’s respective regulatory authority, the Biosimilars Council believes the focus should be placed on the Food and Drug Administration’s (FDA’s) review of public comments received on its draft guidance on naming. The Council will continue working with domestic and international regulatory bodies to finalize regulations that promote pharmaceutical competition, enable access and increase savings for millions of patients.”
Read the IGBA release here.
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.