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Biosimilars Council Urges CMS to Wait on Part B Reimbursement for Interchangeable Biologic Products


Contact: Steve Arnoff 202.249.7113

Regulation is Premature Without FDA Clarity on Interchangeable Biologic Pathway

WASHINGTON, DC (August 25, 2015) — The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), continues to raise concerns about the proposed rule issued by the Centers for Medicare and Medicaid Services (CMS) regarding biosimilars’ reimbursement under Medicare Part B.

“The Biosimilars Council believes that each non-interchangeable biosimilar should receive a unique code,” said Dr. Bertrand C. Liang, Chief Executive Officer, Pfenex, Inc. and Chairman, Biosimilars Council. “However, at this time, the pathway is insufficiently developed by the Food and Drug Administration to support regulation related to coverage, coding and payment of interchangeables.”

While the availability of biosimilars in the United States promises to improve patient access to these new medicines cost-effectively, the Council believes the current CMS proposal to group all biosimilars to the same payment calculation and billing code, separate from the reference product, would discourage innovation and erect barriers todeveloping new biosimilar and interchangeable biologics, decreasing access to these important agents.

“Grouping all biosimilars together under one payment calculation and billing code, while using a different code for the reference product, creates confusion, making it difficult to write coverage policies. In some instances this practice could have the unintended consequence of discouraging investment in the development of new biosimilar and interchangeable products to the detriment of patient access,” said Liang.

The Council will file more detailed comments by the September 8 deadline. The Biosimilars Council looks forward to working with CMS and other stakeholders to help create a robust, competitive market for these medicines, and will continue urging CMS to revise the current proposal.


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 

About GPhA

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 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at Follow us on twitter: @gpha.