December 13th 2022
By Sarfaraz K. Niazi, PhD
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
By Skylar Jeremias
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.
November 30th 2022
Capstone has announced that its human insulin biosimilar received positive opinions from the European Medicines Agency and Health Canada, signaling approvals may be on the horizon, and the acquisition of Viatris’ biosimilars portfolio by Biocon Biologics is officially complete.
November 24th 2022
Iceland-based Alvotech received regulatory approval for AVT02, its biosimilar referencing Humira (adalimumab), from the Therapeutic Goods Administration of Australia.
November 23rd 2022
The FDA has granted Eli Lilly’s long-acting insulin glargine biosimilar, Rezvoglar, an interchangeability designation, making it the second interchangeable insulin biosimilar in the United States.
November 22nd 2022
The Biosimilar Red Tape Elimination Act will seek to increase patient access to biosimilars by reducing switching study requirements for companies to obtain interchangeability designations.
November 15th 2022
The European Union has approved a third biosimilar referencing Lucentis (ranibizumab), STADA Arzneimittel and Xbrane BioPharma’s Ximluci, for the treatment of retinal conditions.
November 9th 2022
Joseph Alvarnas, MD, vice president of government affairs at City of Hope and chief clinical adviser of AccessHope, explains what the recent FDA approvals of Stimufend and Vegzelma, 2 oncology biosimilars, says about the current state of the oncology biosimilar space.
