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Imron Aly, JD: Settlements Over Humira
Imron Aly, JD, partner at Schiff Hardin LLP, explains how European cases influenced US patent litigation over Humira.
Transcript:
Why will US patients have to wait longer for biosimilar adalimumab than EU patients?
The Humira question is really an interesting one. In Europe the patent litigations had already been underway, whereas in the US, they were trailing a little bit behind. So once the first filer for any biosimilar product settled in Europe—setting the dates and everything that went with that—it made it harder for others to challenge it in the US and be incentivized to continue litigation when there was a sure bet and a sure launch date coming up that probably couldn’t have been beaten anyways with a long, drawn-out fight.
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December 27th 2024Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
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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.
Q&A: Dr Kimberly Maxfield Explains How BsUFA III Will Advance the US Biosimilar Industry
December 20th 2023At AMCP Nexus, Kimberly Maxfield, PhD, pharmacologist at the FDA, delved into how the third reauthorization of the Biosimilar User Fee Act (BsUFA III) will shape the American biosimilar market and improve development efficiency over the next few years.
