Group Concerned With CMS Proposal on Biosimilars

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By Bronwyn Mixter

Aug. 25 — The Biosimilars Council, a division of the Generic Pharmaceutical Association, said Aug. 25 the proposed rule issued by the CMS on Medicare reimbursement for biosimilars would discourage innovation and erect barriers to developing these products.

The 2016 proposed physician fee schedule rule released July 8 includes provisions clarifying that the Medicare Part B payment amount for biosimilars is based on the average sales price (ASP) of all biosimilar products that reference the same original biologic's license application (9 LSLR 845, 7/24/15). The Affordable Care Act, through its Biologics Price Competition and Innovation Act, created an abbreviated pathway for the Food and Drug Administration to approve biologic products shown to be similar to, or interchangeable with, an FDA-licensed biological reference product.

In 2010, the Centers for Medicare & Medicaid Services issued regulations on the payment approach for biosimilars that was specified by the ACA. The proposed rule would update the regulations to clarify that biosimilar products that rely on a common reference product's biologics license application would be grouped into the same payment calculation, according to a summary of the rule.

Comments on the proposed rule (CMS-1631-P) are due Sept. 8.

Unique Code Needed 

“The Biosimilars Council believes that each non-interchangeable biosimilar should receive a unique code,” Bertrand C. Liang, chief executive officer, Pfenex Inc., and chairman of the Biosimilars Council, said in a statement. “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.”

Liang said “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,” Liang said.

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

The FDA approved its first biosimilar drug in March (09 LSLR 328, 3/20/15). That biosimilar, Zarxio, is a product of Sandoz (part of Novartis) and is a version of the Amgen cancer drug Neupogen (filgrastim).

To contact the reporter on this story: Bronwyn Mixter in Washington at

To contact the editor responsible for this story: Janey Cohen at

The proposed rule is at

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