The Australian Labor Party has flagged the data exclusivity provisions of the Trans Pacific Partnership Agreement (TPP) as a major issue ahead of our now confirmed July date for an Australian election.
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 for biosimilar products under Medicare Part B, as set forth in a final rule implementing how the Medicare program plans to reimburse biosimilar products.
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