In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|May 6, 2015
Biosimilar Giants Launch Biosimilars Forum
Author(s)BioPharm International Editors
Eleven of the leading US biosimilar developers have collaborated to form the Biosimilars Forum, a nonprofit organization formed to expand patient access to biosimilars.
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On May 5, 2015 some of the leading biosimilar developers in the United States announced the launch of the Biosimilars Forum. The forum was developed by 11 companies with the most significant biosimilars development portfolios: Actavis, Amgen, Boehringer Ingelheim, Coherus BioSciences, EMD Serono, Hospira, Merck, Pfizer, Samsung, Sandoz, and Teva. “The Forum will provide evidence-based information to educate and advocate for public policies and practices that encourage access, awareness, and adoption of biosimilars,” according to a press release.
The officials who will lead the forum were announced in the press release and include:
- President: Juliana Reed, vice-president, Global Government Affairs, Hospira
- Vice-president: Hillel Cohen, PhD, executive director, Scientific Affairs, Sandoz Biopharmaceuticals (a Novartis company)
- Treasurer, Geoffrey Eich, executive director, External Affairs, Amgen Biosimilars
- Secretary, Stacie Phan, director, State Government Affairs and Public Policy, Boehringer Ingelheim.
The forum will submit a public statement on May 7, 2015 to the Centers for Medicare and Medicaid Services Healthcare Common Procedure Coding System to address the need for appropriate coding for biosimilars.
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