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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18th 2024Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.