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Mark Cziraky, PharmD, CLS: Biosimilars and Real-World Data
Mark Cziraky, PharmD, CLS, explains why real-world data are key in the biosimilars marketplace.
Transcript:
How important are real-world data about the safety and efficacy of biosimilars?
Yeah, I think they’re extremely important; real-world evidence and using real-world data to generate real-world evidence is extremely important in this area. Just by the nature of these therapies there is potential for some concern around their effectiveness compared to the comparative agent that they’re built from. So therefore, the fact [is] that we want to get more evidence of their use in the marketplace to show that they are reaching their intended outcomes and not showing the adverse effects that we hopefully won’t see with the products in the market.
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.
