Biosimilars Reimbursement Rule Could Discourage Patient Access

WASHINGTON, DC (October 30, 2015) — The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), is disappointed today by the Centers for Medicare & Medicaid Services' (CMS) decision to group all biosimilars together under one payment calculation and billing code in Medicare Part B, while using a different code for the reference product.

"It is unfortunate that CMS chose to ignore the strong reservations expressed by experts from all corners of the supply chain, leading biosimilar manufacturers and others urging the agency to provide non-interchangeable biosimilars with their own independent billing codes and payment calculations. This final rule is likely to discourage investment in biosimilar therapies, making it harder for patients to access these new more affordable products in the United States," said Chip Davis, President and CEO of GPhA.

"There is no scientific evidence that suggests it would be appropriate to blend all biosimilar products into a single payment calculation, independent of the reference product," said Bert Liang, CEO of Pfenex Inc., and Chairman of the Biosimilars Council. "While we appreciate CMS' recognition that it would be premature to issue a rule regarding reimbursement for future interchangeable biosimilars, placing all non-interchangeable products in a single code independent of the reference product is still misguided. Non-interchangeable products are solely compared to the reference product, and not one another, making this arrangement highly unusual."

The Biosimilars Council continues to look forward to working with CMS to develop policies that will encourage patient access to biosimilars and promote savings to the U. S health care system. 

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.

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