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Robert Cerwinski: Healthcare Reform and the BPCIA
Robert Cerwinski, JD, Partner at Goodwin, discusses what becomes of the BPCIA if the Affordable Care Act is repealed by Congress.
Transcript:
If the [Affordable Care Act, ACA] is repealed, what becomes of the [Biologics Price Competition and Innovation Act, BPCIA]?
So, the BPCIA is part of the ACA, and if Congress repeals it lock, stock, and barrel, without having some replacement ready to go, technically the BPCIA goes with it, right? I don’t think any of us expect that that’s going to happen, but I’ll tell you that with the current administration and with the current Congress, uncertainty seems to be the rule. The BPCIA so far, in all the debate that we have been hearing and monitoring in Congress and in the administration, seems to be flying completely under the radar. It does not appear to be one of the controversial aspects of Obamacare that the president and Congress are really focused on. From that standpoint, that’s good for biosimilar applicants, but again, because there is this uncertainty, we have at least been watching it. I think I can say that nobody really expects the BPCIA to go away, and we don’t think it is seriously at risk, but certainly we watch what Congress is doing in this respect.
Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results
August 21st 2024Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.
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.
Eye on Pharma: Canadian Aflibercept Settlement; Sandoz Acquires Cimerli; Payer Chooses Cyltezo
March 6th 2024Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.
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.
Patient With MS Sues J&J Over ERISA Violation
February 14th 2024After a patient with multiple sclerosis (MS) was forced to pay exorbitant out-of-pocket costs for a brand name medication when she could’ve gotten a generic for way less, the patient filed a class action complaint against her employer, Johnson & Johnson (J&J), for violating the Employee Retirement Income Security Act of 1974 (ERISA).
What Types of Patents Are to Blame for Biosimilar Market Delays?
January 29th 2024Although manufacturing patents tend to be the most common type of patent referenced in litigation regarding biosimilar development, other patents actually have a greater impact on delays for biosimilar market launches.
