This past December, the U.S. Food and Drug Administration (FDA) issued a biosimilar industry guidance on a variety of topics. Mostly overlooked was a Q&A regarding safety protections in a 351(k) application. The FDA Commissioner thought the matter was important enough to single out in his comments released the same day, calling it a "critical issue."
FDA noticed that reference product holders have been limiting supplies of the reference drug to prospective 351(k) biologics license application (BLA) applicants, apparently in an effort to delay biosimilar applications.
Specifically, several companies have refused to sell the reference product, citing as justification the purported inability of the prospective applicants to follow the required risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) safety standards. Without samples of the product, biosimilar sponsors cannot proceed with their BLAs.
In the Q&A, FDA commits to
If FDA determines that the safety protections are comparable, the prospective applicant may request that FDA
|Braginsky, Philip Partner and Co-Chair of Intellectual Property Group and Pharmaceutical and Biologics Practice and China Practice||Partner and Co-Chair of Intellectual Property Group and Pharmaceutical and Biologics Practice and China Practice||212.216.8065|