- 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.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
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.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
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.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
