Biosimilars Forum Statement Regarding FDA’s Draft Guidance for Industry on Interchangeability for Biosimilar Products
WASHINGTON, January 17, 2017 – The Biosimilars Forum – the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States – today issued the following statement regarding the Food and Drug Administration’s (FDA) draft guidance for industry on interchangeability for biological products.
“The Biosimilars Forum is pleased that the FDA has published its draft guidance on interchangeability. 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. The Forum will be analyzing the specific terms of the draft proposal and will submit formal comments to FDA, and hopes the agency will publish final guidance in the near future.”
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