- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Alexandra Valenti, JD: Regulatory Scrutiny and Biosimilar Settlements
Alexandra Valenti, JD, partner at Goodwin, discusses whether drug makers are given pause by the possibility of regulatory scrutiny of patent settlements.
Transcript
So, the [Federal Trade Commission, FTC] and the [Department of Justice, DOJ] did an analysis following both the [Medicare Modernization Act, MMA’s] enactment of the regulatory review provision as well as the Supreme Court’s decision in FTC v Actavis that held that “pay-for-delay” agreements can be subject to antitrust review.
So, FTC’s analysis showed that both of those things did result in a decrease in the number of potentially problematic settlement agreements, again in the small-molecule context, that were being submitted for review. So, in terms of whether this will affect biologics’ patent settlement agreements, I think we’ll have to see what comes of the enhanced regulatory scrutiny. And there is also an open question as to whether the reasoning of the Supreme Court’s decision in FTC v Actavis regarding the antitrust issue extends to biologics. And so, it’s kind of a wait and see, I think.
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.
