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Lee Schwartzberg, MD, FACP: Biosimilar Education for Oncologists
Lee Schwartzberg, MD, FACP, The West Clinic, explains the kinds of education that oncology providers still need to feel comfortable with biosimilars.
Transcript
I think biosimilar education is still needed to understand the regulatory difference between the originator product, which has to show in phase 3 trials that it's better or noninferior to another agent, and that it has efficacy and safety. The FDA approves initial drugs based on efficacy and safety. Biosimilars are approved with less clinical evidence because they're really mirroring the originator products, so it's highly technical in terms of the analytic variables that have to be satisfied for a biosimilar compared to an originator. As oncologists understand that process better, they'll become more comfortable with it.
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.
