Molly Burich, MS, head of public policy at Boehringer Ingelheim (BI), discusses how the FDA's new guidance on interchangeability designation will improve confidence and acceptance for biosimilars during the World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California.
Molly Burich, MS, is the head of public policy at Boehringer Ingelheim.
Transcript:
What are your thoughts on the FDA's updated guidance on interchangeability?
I think the FDA has long been a proponent of not just the biosimilar pathway, but obviously getting interchangeables approved as well. From a guidance perspective, [Boehinger Ingelheim] has felt strongly that the FDA has gotten the guidance right, both in proposed and final form. We believe there does need to be an appropriately high bar, but at the same time, some product-by-product flexibility. We want to make sure that the interchangeability designation is in fact meaningful; that it’s generating a complement of data around patient switching that will help drive physician confidence and patient acceptance as well.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.