Biosimilars Forum Submits Comments in Response to FDA’s Draft Guidance for Industry on Interchangeability for Biosimilar Products
WASHINGTON, DC, May 3, 2017 – The Biosimilars Forum — the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States — today submitted comments in response to the Food and Drug Administration’s (FDA) draft guidance for industry on interchangeability for biological products. Read the full comments here.
“The Biosimilars Forum appreciates FDA’s efforts to publish this Draft Guidance document clarifying its expectations with regard to the data required from a sponsor in order to demonstrate interchangeability. In addition to the specific comments to the Draft Guidance, the Forum urges the FDA to consider, on a case-by-case basis, the practicality and feasibility of switching study expectations to support a determination of interchangeability, and to ensure there is flexibility in approach when appropriately justified. Biosimilars hold the promise of reducing healthcare costs while providing additional treatment choices for patients. FDA guidance is critical to helping manufacturers develop these products.”
About the Biosimilars Forum
The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios.
Aimee Steel Lubin