In mid-January , the US Food and Drug Administration (FDA) published long-awaited draft guidelines for industry on how best to demonstrate a biosimilar’s interchangeability with its reference product.
Industry was given until March 18 to submit electronic or written comments, but the Agency has extended this until May 19 “in response to several requests for an extension to allow interested persons additional time to submit comments.”
Industry group BIO requested the sixty-day extension of time in a comment submitted to the FDA on February 17 claiming many of the issues brought up in the guidance “are being evaluated by the industry for the first time.”
“Proper analysis, therefore, and understandably, will require more time than the currently allotted period,” BIO executives Cartier Esham and John Murphy said in an electronic submission.
“An extension will provide the industry valuable time to hopefully coalesce around unified comments to communicate to the Agency for consideration in finalizing the Draft.”
Pharmaceutical Research and Manufacturers of America (PhRMA) also called for an extension to review and craft appropriate responses “given the numerous scientific and regulatory issues addressed in this draft guidance on an important topic,” as did international law firm Covington & Burling on February 7 .
Among the recommendations laid out in the document, the FDA is calling for a switching study (or studies) to demonstrate the risk in terms of safety or diminished efficacy of alternating between a biosimilar and its reference product is not greater than the risk of using the reference product without such switch.
The document was welcomed by biosimilar makers in January – Pfenex described it as “an important step in creating a robust market for biosimilars in the United States” – and developers told this publication they were busy reviewing the document.
Amgen, for example, said it was unable to comment on the “fairly dense” guidance at the time.