Blog
RSS FeedPosted by Michael Wonder on 30 Aug 2022
Outlook Therapeutics re-submits biologics license application for ONS-5010 as a treatment for wet AMD to the US FDA
30 August 2022 - Outlook Therapeutics today announced it has re-submitted its biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 22 Aug 2022
Three imperatives for R&D in biosimilars
19 August 2022 - The biosimilars market is poised to grow over the next decade. ...
Posted by Michael Wonder on 17 Aug 2022
Samsung Bioepis and Organon announce FDA approval of citrate free high concentration Humira biosimilar Hadlima (adalimumab-bwwd)
17 August 2022 - Samsung Bioepis and Organon today announced the U.S. FDA has approved the citrate free, high concentration (100 ...
Posted by Michael Wonder on 03 Aug 2022
Fresenius Kabi’s biologics license application for biosimilar candidate tocilizumab accepted for review by the FDA
1 August 2022 - Fresenius Kabi announced today that the U.S. FDA has accepted for review the company’s 351(k) biologics ...
Posted by Michael Wonder on 03 Aug 2022
FDA approves Coherus’ Cimerli (ranibizumab-eqrn) as the first and only interchangeable biosimilar to Lucentis for all five indications, with 12 months of interchangeability exclusivity
2 August 2022 - First Cimerli product sales expected in October 2022. ...
Posted by Michael Wonder on 25 Jul 2022
Applications for proposed first of a kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA
25 July 2022 - Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple ...
Posted by Michael Wonder on 21 Jul 2022
Sandoz supplemental biologics license application accepted by US FDA for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation
21 July 2022 - Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study. ...
Posted by Michael Wonder on 06 Jun 2022
FDA approves Riabni (rituximab-arrx), a biosimilar to Rituxan (rituximab), for adults with moderate to severe rheumatoid arthritis
6 June 2022 - Now approved to treat all available Rituxan Indications. ...
Posted by Michael Wonder on 02 Jun 2022
Biogen and Samsung Bioepis’ Byooviz (ranibizumab-nuna) launches in the United States
2 June 2022 - Byooviz, priced 40% lower than Lucentis, provides an equally effective and more affordable treatment option to patients ...
Posted by Michael Wonder on 31 May 2022
Xbrance provides update on ranibizumab biosimilar candidate FDA filing
30 May 2022 - Xbrane Biopharma has withdrawn its biologics license application for its investigational biosimilar candidate to Lucentis after ...
Posted by Michael Wonder on 28 May 2022
Amneal achieves third U.S. biosimilar approval with Fylnetra (pegfilgrastim-pbbk)
27 May 2022 - Marks Amneal’s third biosimilar approval in 2022. ...
Posted by Michael Wonder on 13 Apr 2022
Amneal achieves second U.S. biosimilars approval with Alymsys (bevacizumab-maly)
13 April 2022 - Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022. ...
Posted by Michael Wonder on 12 Mar 2022
Biosimilar impact on oncology clinical trial design and operations
11 March 2022 - There is a wealth of data, reviews, articles, and regulatory guidance on how to conduct clinical trials ...
Posted by Michael Wonder on 08 Mar 2022
FDA offers funding for biosimilar regulatory science pilot
7 March 2022 - The US FDA is offering funding for several research proposals under the regulatory science pilot for ...
Posted by Michael Wonder on 03 Mar 2022
Amneal enters U.S. biosimilars market with approval of Releuko (filgrastim-ayow)
1 March 2022 - First of three Amneal biosimilars expected for U.S. approval and launch in 2022. ...