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Ha Kung Wong, JD: Noteworthy Ongoing Biosimilar Litigation
Ha Kung Wong, JD, partner at Venable LLP, addresses ongoing biosimilar cases that stakeholders are watching closely.
Transcript:
Are there some ongoing cases that biosimilar stakeholders are watching closely at the moment?
Pfizer v Johnson & Johnson, which is in the Eastern District of Pennsylvania, the first antitrust case between a biosimilar manufacturer and a reference biologic sponsor. That case involves the biologic Remicade (which is infliximab) and alleges that Johnson & Johnson engaged in a plan to keep Pfizer’s biosimilar Inflectra off the market. According to Pfizer, Johnson & Johnson had a plan involving exclusive contracts with insurance companies, which included reimbursement schemes, explicit promises not to cover Inflectra, and bundling arrangements which resulted in Pfizer’s biosimilar being kept off medical plans or only being available for patients who have already failed on Remicade.
Johnson & Johnson had filed a motion to dismiss the complaint, but it was recently denied on August 10. Stakeholders are going to continue to follow this case very carefully, though, to see how the courts will apply antitrust laws to the complex world of biosimilar competition.
A second set of cases that stakeholders are following are AbbVie v Boehringer Ingelheim in the District of Delaware and AbbVie v Sandoz in the District of New Jersey which are both pending cases* involving biosimilars of Humira.
We’ve seen that AbbVie has already settled with Mylan, Samsung Bioepis, and Amgen related to their US biosimilar versions of Humira, which will keep these biosimilars off the market until around 2023. AbbVie has also settled with Samsung Bioepis/Biogen and Amgen concerning their biosimilars of Humira in the [European Union, EU]. It will be interesting to see if these settlements continue, particularly with respect to Boehringer Ingelheim considering its biosimilar.
*at the time of filming. AbbVie and Sandoz have since reached a settlement.
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.
