- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Scott Lassman: FDA and the BPCIA
Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, discusses whether the FDA might involve itself in answering the lingering questions concerning the Biologics Price Competition and Innovation Act (BPCIA).
Transcript:
Do you foresee the FDA stepping in to clarify issues concerning the BPCIA?
Well, they have issued a number of guidance documents and draft guidance documents. I think they’re going to continue to finalize the draft guidance documents they’ve got out there. I don’t think there’s a lot more on the horizon.
The question about [whether they’re] going to do something in response to the court cases is another interesting question; I actually don’t think they are.
The 1 thing they could do, it would be easy, and this is to me the 1 thing they might do, is they could basically say that for biosimilars there is such a thing as tentative approval. That would address some of the issues that have been swirling around as to when you can give the notice that you’re going to start marketing.
That would be very consistent with what they do with [abbreviated new drug applications, aNDAs] and what they do with 505b2 applications, so I don’t think that would be much of a stretch for them. But they really do not want to get involved in any of this BPCIA litigation. I know the courts and some of the litigators are trying to pull them in; I think they’re going to push back and try not to get roped in. At least that’s my guess.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
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.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
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.
