- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Robert Cerwinski: Biosimilars, Legal Complexities, and Europe
Robert Cerwinski, JD, partner at Goodwin, explains the differences between European and US patent challenges for biologics.
Transcript:
Have biosimilars faced legal complexities in Europe similar to those in the United States?
The short answer is: not as much. The principal reason why, is in the European Patent Office, the EPO, there has been a very robust opposition proceeding for many years. What this has allowed is for biosimilar applicants to challenge patents that stand in the way of marketing a biosimilar early and effectively. We see now with IPRs (inter partes reviews) and PGRs (post-grant reviews) in the US, we see something akin to the European Patent Office (EPO) style oppositions, but IPRs and PGRs are quite a bit different. Arguably, it’s not as efficient of a mechanism. By the time the EMA approves a biosimilar, the biosimilar applicant has a number of years to use this very robust opposition proceeding in the EPO to try to clear patents away. So, it’s been easier for biosimilar applicants in Europe to actually reach market.
PBM Evolution Toward Value-Based Care Shifts to Transparent Pharmacy Pricing
March 30th 2025Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, predict pharmacy benefit managers (PBMs) will evolve toward value-based care, mirroring the broader shift toward open-cost structures.
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?
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
