17 May 2021 - Decision not to review Federal Circuit July 2020 ruling continues to prevent Sandoz launch of more affordable ...
5 May 2021 - Permitting automatic substitution of biosimilars for originator brand biologics at the pharmacy counter is often talked about ...
17 February 2021 - Coherus BioSciences announced that the United States FDA has accepted for review the 351(k) biologics license application ...
28 January 2021 - Bio-Thera Solutions today announced that the U.S. FDA has accepted its biologics license application for BAT1706, a ...
6 January 2021 - Product differentiation by concentration is a threat to the multiple adalimumab biosimilars approved but not yet ...
27 December 2020 - For Bengaluru, Karnataka, India–based Biocon Biologics, the pandemic has interrupted the FDA review process for its ...
17 December 2020 - Fifth FDA Approval From Amgen's Biosimilars Portfolio. ...
10 December 2020 - Arguing the FDA is precluding competition for biosimilar manufacturers, Boehringer Ingelheim has petitioned the agency to ...
19 November 2020 - Alvotech is developing AVT02 as a proposed biosimilar to Humira (adalimumab) with high concentration (100 mg/mL) dosage ...
18 November 2020 - Samsung Bioepis and Biogen today announced that the U.S. FDA has accepted for review the biologics license ...
18 November 2020 - The reference product rights holder contends that Centus has not provided complete information about its manufacturing ...
4 November 2020 - The way Sarfaraz K. Niazi, looks at it, doing comparative efficacy studies in humans to confirm that ...
14 October 2020 - Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation ...
11 October 2020 - Average clinical efficacy testing cost millions of dollars more for Phase 3 biosimilar studies than for ...
15 September 2020 - Representative Glenn Grothman, (R-Wisconsin), says interchangeability for insulins makes sense based on the savings potential and safety ...