January 17th 2023
By Skylar Jeremias
Health Canada has granted approval for Celltrion Healthcare’s bevacizumab biosimilar (Vegzelma) referencing Avastin for the treatment of multiple forms of cancer.
January 16th 2023
The China National Medical Products Administration (NMPA) approved Bio-Thera Solutions’ tocilizumab biosimilar (BAT1806) referencing Actemra for the treatment of several rheumatic conditions.
January 9th 2023
Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, demonstrates why regulatory bodies in the United States shouldn't look at economic evaluations when reviewing regulatory data for biosimilars in his latest column.
January 6th 2023
Alvotech, an Iceland-based company, announced that the FDA accepted its biologics license application (BLA) for its proposed ustekinumab biosimilar referencing Stelara. The company said it expects the FDA’s decision in the second half of 2023.
January 5th 2023
Celltrion Healthcare submitted a biologics license application (BLA) to the FDA for its biobetter of its infliximab biosimilar allowing for subcutaneous administration (Remsima SC).
January 4th 2023
By Sarfaraz K. Niazi, PhD
Sarfaraz K. Niazi, PhD, summarizes some of the lessons that the entire biosimilar industry can take away from 2022, including what new legislation and policy changes could mean for future biosimilar development.
January 3rd 2023
Health Canada has approved the high-concentration version of Samsung Bioepis and Organon’s Hadlima, a citrate-free adalimumab biosimilar referencing Humira.
December 28th 2022
Ian Henshaw, senior vice president and global head of biosimilars at Biogen, shares his thoughts on whether clinical efficacy and switching studies to establish biosimilar safety are necessary, a hotly debated topic in the biosimilars industry.
December 21st 2022
Over 2 years after a cabinet vote to establish a biosimilar switching policy, the Ontario government is putting one in place, making it the seventh province and eighth jurisdiction in Canada to do so.
December 17th 2022
By Deana Ferreri, PhD
Despite recent steps taken by the FDA to streamline approvals and increase availability for biosimilars, biosimilar adoption has been slow and primarily driven by payers in the United States, signaling that more needs to be done to encourage adoption, according to experts at a virtual workshop hosted by the FDA and the University of Maryland.
