- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Alexandra Valenti, JD: The 2020 Transition of Insulins to Regulation as Biologics
Alexandra Valenti, JD, partner at Goodwin, discusses what drug makers should consider as the United States approaches a regulatory transition for insulins.
Transcript
So, the FDA has released guidance indicating that insulin and other products that, for historical reasons, were previously regulated as small molecules will be transitioned to be regulated as biologics. And, this raises a couple issues for drug manufacturers.
One is that if you submit an application for, let’s say insulin, ahead of the transition date in March of 2020 and the application is not yet approved as of March 23, 2020, your application would need to be resubmitted under what will be the new framework for that product under the biologics regulatory framework.
So, that creates this period that we’re in right now, really, where companies probably won’t be filing applications on these products because there’s that risk of not being approved in time and then having to restart the whole process. So, it just makes more sense to wait until March 2020, basically, to go ahead and submit the application.
The other issue is if those new applications do have to get filed, what are the consequences of that? Does it reinitiate patent dance procedures under the [Biologics Price Competition and Innovation Act, BPCIA]? Other kind of regulatory issues having to do with the new application that you would need to submit, and so we do have this situation now where there is sort of a disincentive to go ahead and file applications on these molecules because there is so much uncertainty about what happens on the transition date if I’m under development as it stands now.
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.
