April 29th 2024
The approval marks the sixth for a biosimilar referencing Herceptin (trastuzumab) for the treatment of HER2-positive breast and gastric cancers.
Roundup: Adalimumab Biosimilar Advancements and a Biosimilar Pill
September 17th 2021Alvotech gains an EU marketing recommendation for AVT02, a proposed adalimumab biosimilar; New Zealand may give preferential status to Amgen's adalimumab biosimilar; BioFactura looks to deliver ustekinumab via a robotic pill.
BIO Attorneys Discuss the BPCIA Patent Dance
September 15th 2021The “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA) is meant to resolve litigation efficiently, and it does, although in practice biosimilar developers and originator companies may not completely adhere to the prescribed steps, according to Biotechnology Innovation Organization (BIO) experts.
ASBM Appoints New Chair in Battle Against Nonmedical Switching
September 14th 2021The Alliance for Safe Biologic Medicines (ASBM) has fought since 2010 in opposition of payer policies that promote automatic switching to cheaper biologics including biosimilars. The group's new chair is no newcomer to this battle.
IPC Guidance Is Issued on Safety of Biosimilar Switching in Psoriasis
August 25th 2021The International Psoriasis Council (IPC) reaches consensus on switching, patient agreement, and biosimilar safety and efficacy qualification. The IPC guidance is conservative when it comes to substitution of these products.
Opinion: A Modified 351(a) Licensing Pathway for Biosimilars
August 21st 2021Use of the 351(k) biosimilar approval pathway entails legal challenges, high costs, and potentially higher clinical evidence standards. Sarfaraz K. Niazi, PhD, suggests that using the 351(a) pathway for standalone drugs and copy products may be faster and better. This is part 3 of a series.
Chad Pettit, MBA, Discusses Amgen’s Biosimilar Trends Report and the Future of Biosimilars in the US
August 18th 2021Chad Pettit, MBA, executive director of Marketing and the Global Biosimilars commercial lead for Amgen, discussed the company’s 2021 Biosimilar Trends Report and his projections for the future of the biosimilars market.