February 7th 2023
Geoff Biegler, JD, a principal at Fish & Richardson, an intellectual property law firm, expands on his presentation on biosimilar legal challenges throughout 2022, providing insight on the inner workings of the patent dance and how a Supreme Court decision could have an impact on future cases.
Contributor: The Trouble With IP for Digital Health and Precision MedicineJuly 18th 2022
Two experts in biosimilar intellectual property (IP) law break down the issues that digital health and precision medicine face with IP and the history of case law that has created the current landscape.
Contributor: No Animal Testing of Biosimilars—US Congress Begins Amendment to BPCIAJune 27th 2022
Sarfaraz K. Niazi, PhD, a professor and biosimilar advocate, chronicles the current efforts to remove animal testing from application requirements for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA), including recent congressional action.
Pfizer Settles 2 Lawsuits, Starts Another Over Etanercept Biosimilar in AustraliaMay 16th 2022
After agreeing to settle with Amgen over its oncology biosimilars, Pfizer issued a new patent lawsuit against 5 companies over the development of Brenzys, an etanercept biosimilar, in Australia.
The US Is Entering Round 2 of Biosimilar Activity, Says Cardinal Health’s OskoueiMay 3rd 2022
The United States is about to enter round 2 of biosimilar activity with a pipeline that expands biosimilars into new therapeutic areas, said Sonia Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars, Cardinal Health, during her presentation at Asembia’s Specialty Pharmacy Summit.
AbbVie Settles ITC Case With Alvotech; Humira Biosimilar to Launch July 2023March 8th 2022
AbbVie settles outstanding lawsuits, including its case related to the International Trade Commission (ITC), with Alvotech, giving Alvotech the green light to launch its high-concentration, citrate-free adalimumab biosimilar referencing Humira in July 2023, pending FDA approval.
In Iceland, Switch to Adalimumab Biosimilar Reveals Issues With Injection DeviceFebruary 15th 2022
Iceland’s national health plan required patients to switch from Humira to the Samsung Bioepis biosimilar, Imraldi, which had a different injection device and contained citrate, a chemical buffer used to maintain the medication’s stability.
FDA Official Addresses Unanswered Questions About Interchangeable BiosimilarsNovember 10th 2021
Sarah Yim, MD, provided a point-by-point overview of the FDA's efforts to clarify the role of the interchangeable biosimilar designation, improve communication with manufacturers, and pay for biosimilar regulatory reviews.
Court Dismisses AbbVie's Trade Secret Piracy Case Against AlvotechOctober 7th 2021
A US District Court in Illinois has ruled that although trade secret theft may have occurred over an adalimumab biosimilar candidate, it happened far from the state. With only a very "attenuated" connection, there are no grounds to bring action against Alvotech in the case of purloined manufacturing data, the judge stated.