FDA Quietly Approves Denosumab Biosimilars, Issues Interchangeability for Others
On Nov. 13, 2025, the U.S. Food and Drug Administration (FDA) approved multiple denosumab biosimilars, enhancing market access…
FDA to Accelerate Biosimilar Development and Lower costs
On Oct. 29, 2025, the U.S. Food and Drug Administration (FDA) announced it is aiming to reduce the…
Celltrion receives U.S. FDA approval for EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept)
On Oct. 9, 2025, Celltrion announced announced that the U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), biosimilar…
Celltrion USA announces U.S. launch of denosumab biosimilars, STOBOCLO® and OSENVELT® (denosumab-bmwo)
On Jul. 7, 2025, Celltrion announced that STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab)…
U.S. FDA approves Celltrion’s OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
On Mar. 9, 2025, Celltrion announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and…
Biotechnology | Disease | FDA | Therapeutics
FDA approved interchangeable biosimilar for multiple inflammatory diseases
On Oct. 31, 2023, the U.S. Food and Drug Administration (FDA) announced it had approved Amgen’s Wezlana (ustekinumab-auub)…
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 The U.S. Food and Drug Administration (FDA) approved filgrastim-sndz (Zarxio, Sandoz, Inc.), the…