January 5th 2023
By Skylar Jeremias
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.
December 13th 2022
In his newest column, Sarfaraz K. Niazi, PhD, looks into the domestic and international support for removing interchangeability for biosimilars in the United States.
December 12th 2022
The FDA has accepted Biogen’s biologics license application for a tocilizumab biosimilar candidate (BIIB800) referencing Actemra for review.
December 4th 2022
On this episode of Not So Different, we recap some of the big regulatory news to come out of November, including some progress for insulin biosimilars, the European approval of another ranibizumab biosimilar, and the congressional introduction of a US Senate bill that is seeking to nix switching study requirements for interchangeability.
December 1st 2022
In November, several global agencies progressed insulin biosimilars, the European Union approved another ranibizumab biosimilar, and a US Senate bill to rid switching study requirements for interchangeability was introduced to Congress.
