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Imron Aly, JD: FTC and DOJ Involvement in Biologics Settlements
Imron Aly, JD, partner at Schiff Hardin LLP, discusses a recent law that will involve new regulatory oversight of biologics settlements.
Transcript:
What are the implications of the recently passed law to have the Federal Trade Commission (FTC) and Department of Justice (DOJ) review settlements between brand manufacturers and biosimilar developers?
Having the DOJ and the FTC review settlements is the norm already in the small-molecules world, so it won’t be anything unexpected or different for the biologics world. As a policy it’s been enforced quite strictly; in fact, since that policy had taken place for small molecules there’s been over 12 challenges by the FTC against individual settlements.
So, there’s been a very aggressive tack. I will add on here at the P4 conference this year an FTC representative came to speak and she explained that the FTC will be continuing to be aggressive in all settlement enforcements for anything of value and just a launch date, and I expect that the same will stay true for biologics.
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.
