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 Hulioï¾® (adalimumab-fkjp)
On Jul. 9, 2020, Mylan and Fujifilm Kyowa Kirin Biologics announced the FDA had approved Hulioï¾® (adalimumab-fkjp), a…
Biotechnology | COVID-19 | Disease | FDA | Life Science News | Therapeutics
Novartis announced plan to initiate clinical study of Jakavi in severe COVID-19 patients
On Apr. 20, 2020, Novartis has reached an agreement with the FDA to proceed with a Phase III…
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…
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…