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Imron Aly, JD: Minimizing Uncertainty in Biosimilar Patent Litigation
Imron Aly, JD, partner at Schiff Hardin, LLP, explains how biosimilar developers can minimize uncertainty in patent litigation.
Transcript:
What are some ways that biosimilar developers can minimize uncertainty in the patent litigation process?
Sure—I’m glad you limited the question to the litigation process because in the regulatory side there is a lot of uncertainty that’s still going on. For example, just today* when it comes to Herceptin, the FDA is asking for more information before even considering the request Pfizer has made.
On the litigation side, I would focus on 2 things. One, identifying the patent landscape for the amount and number of patents that are or could be applicable and 2, identifying early experts that would be available for each of those individual patents.
Those are 2 areas where if there isn’t activity early enough, a lot of unpredictable things can happen.
*date of filming.
How Vertical Integration Drives Innovation and Access in Biosimilars
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.
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.
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.
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.
