- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Imron Aly, JD: Hatch-Waxman and BPCIA Litigation
Imron Aly, JD, partner at Schiff Hardin, LLP, explains how lessons learned from Hatch-Waxman proceedings can be applied to Biologics Price Competition and Innovation Act (BPCIA) litigation.
Transcript:
Are there lessons learned from Hatch-Waxman proceedings that you think can be applied to Biologics Price Competition and Innovation Act [BPCIA] litigation?
Yes—I would say that the BPCIA litigation is Hatch-Waxman on steroids. The reason I can say that is because we’re seeing a lot of brand-versus-brand interactions. Amgen, Pfizer…they all want to get into the biosimilars game, when in historical times, not so long ago, they were all making brand drugs, trying to stave off competition.
So what you’re going to now see is a lot of emerging trends about any ideas people had at Hatch-Waxman, where, from a generic company point of view, they’d have to pick and choose to prioritize specific arguments to fit within tighter budgets, now, on a brand-versus-brand larger scale, we can leave no stone unturned and be able to investigate a lot of issues and really dig down into the dip issues of invalidity, prior sale, prior use, anything that goes to invalidating those prior patents in the biosimilars world.
And those are things that are from the Hatch-Waxman space, but carried over really to a further extent on the biosimilars side.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors
March 11th 2025The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.
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.
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.
Top 5 Most-Read Legal Articles of 2024
December 23rd 2024The top legal stories in biosimilars from 2024 emphasize the ongoing struggle between ensuring timely patient access and addressing challenges like litigation, regulatory hurdles, and patent disputes that shape the competitive landscape of affordable biologics.
