Tag archives: biosimilars and biologics

Congressional hearing on the reimbursement of biosimilars draws criticism of CMS’s existing payment policy

On February 4th, the Energy & Commerce Committee’s subcommittee on health held a legislative hearing regarding the implementation of the Biologics Price Competition and Innovation Act, which established a shortened FDA approval process for determining when biosimilar products are considered interchangeable with previously-approved FDA products.  The subcommittee members expressed concerns regarding plans to reduce reimbursement … Continue reading

FDA issues three final guidances on biosimilars

On Tuesday, April 28, FDA finalized three “guidances to the industry” that describe FDA’s standards for approving biosimilar products (biosimilars). A biosimilar is a biological product approved by the FDA based on a showing that (1) it is highly similar to an FDA-approved biological product (reference product), and (2) has no clinically meaningful differences in … Continue reading