FDA approved interchangeable biosimilar for multiple inflammatory diseases
On Oct. 31, 2023, the U.S. Food and Drug Administration announced it had approved Amgen’s Wezlana (ustekinumab-auub) as…
U.S. FDA approved first biosimilar to treat Multiple Sclerosis
On Aug. 24, 2023, the U.S. Food and Drug Administration approved Sandoz’s Tyruko (natalizumab-sztn), the first biosimilar to…
Mylan and Fujifilm Kyowa Kirin Biologics announced FDA approval of Hulioﾮ (adalimumab-fkjp)
On Jul. 9, 2020, Mylan and Fujifilm Kyowa Kirin Biologics announced the FDA had approved Hulioﾮ (adalimumab-fkjp), a…
Novartis announced plan to initiate clinical study of Jakavi in severe COVID-19 patients
On Apr. 20, 2020, Novartis announced it had reached an agreement with the U.S. Food and Drug Administration…
iBio supporting AzarGen Biotechnologies’ development of a Rituximab biosimilar at Bryan, Texas facility
On Mar. 26, 2020, iBio announced that it had entered into a development agreement with AzarGen Biotechnologies. Signed…
Biotechnology | Disease | FDA | Oncology | Therapeutics
FDA approved first biosimilar for the treatment of certain breast and stomach cancers
On Dec. 1, 2017, the U.S. Food and Drug Administration (FDA) approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar…
The first biosimilar Zarxio (Filgrastim-sndz) was approved by the FDA
On Mar. 6, 2015, the FDA approved filgrastim-sndz (Zarxio, Sandoz, Inc.), the first biosimilar product available in the…