9 December 2022 - Biogen announced that the US FDA has accepted for review the abbreviated biologics license application for ...
23 November 2022 - The FDA has granted Eli Lilly’s long-acting insulin glargine biosimilar, Rezvoglar, an interchangeability designation, making it ...
28 September 2022 - The approval is based on totality of evidence with no clinically meaningful differences in efficacy or safety ...
6 September 2022 - Fresenius Kabi’s first approved U.S. biosimilar. ...
30 August 2022 - Outlook Therapeutics today announced it has re-submitted its biologics license application to the U.S. FDA for ...
19 August 2022 - The biosimilars market is poised to grow over the next decade. ...
17 August 2022 - Samsung Bioepis and Organon today announced the U.S. FDA has approved the citrate free, high concentration (100 ...
1 August 2022 - Fresenius Kabi announced today that the U.S. FDA has accepted for review the company’s 351(k) biologics ...
2 August 2022 - First Cimerli product sales expected in October 2022. ...
25 July 2022 - Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple ...
21 July 2022 - Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study. ...
6 June 2022 - Now approved to treat all available Rituxan Indications. ...
2 June 2022 - Byooviz, priced 40% lower than Lucentis, provides an equally effective and more affordable treatment option to patients ...
30 May 2022 - Xbrane Biopharma has withdrawn its biologics license application for its investigational biosimilar candidate to Lucentis after ...
27 May 2022 - Marks Amneal’s third biosimilar approval in 2022. ...