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Carol Lynch: Instilling Confidence in Biosimilars
Carol Lynch, president of Sandoz US and head of North America, discusses the FDA's role in instilling confidence in biosimilars.
Transcript:
What kind of responsibility does the FDA have to assure providers and patients that biosimilars are safe and effective products?
So obviously, FDA play a clear role in educating all stakeholders around the misinformation [about biosimilars], but they also have an important role in terms of the confidence that they can instill in physicians and patients around biosimilars. These products undergo a rigorous review by FDA and patients and healthcare providers alike should be confident in their efficacy and the safety and the quality of the products. FDA could help us with that by reinforcing that confidence when new approvals are announced, for example.
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.
