TPP and biologics – a battleground in Australian elections

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on May 10, 2016 Posted in FDA & Food Safety

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.… Continue reading

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

By on February 5, 2016 Posted in News from DC, Regulatory

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

By Gina Shishima (US) and Carol Poindexter (US) on May 4, 2015 Posted in FDA & Food Safety

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