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: No Animal Testing of Biosimilars—US Congress Begins Amendment to BPCIA
June 27th 2022Sarfaraz 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.
The US Is Entering Round 2 of Biosimilar Activity, Says Cardinal Health’s Oskouei
May 3rd 2022The 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 2023
March 8th 2022AbbVie 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 Device
February 15th 2022Iceland’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 Biosimilars
November 10th 2021Sarah 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 Alvotech
October 7th 2021A 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.