Blog
RSS FeedPosted 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30 May 2022 - Xbrane Biopharma has withdrawn its biologics license application for its investigational biosimilar candidate to Lucentis after ...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. ...
Posted by Michael Wonder on 03 Mar 2022
FDA accepts Alvotech’s BLA supporting interchangeability for ATV02, a high concentration, citrate-free biosimilar candidate for Humira
28 February 2022 - Alvotech is the only known company to have both developed a high-concentration biosimilar to Humira and ...
Posted by Michael Wonder on 14 Feb 2022
Medscape awarded contract from FDA to develop educational programming focused on biosimilars
14 February 2022 - Medscape Education has been awarded a contract from the U.S. FDA for the development of an ...
Posted by Michael Wonder on 22 Jan 2022
Patent thickets are thwarting U.S. availability of lower cost biosimilar medicines, study finds
18 January 2022 - Amid debate over competition in the pharmaceutical industry, a new analysis found just 6% of patents ...
Posted by Michael Wonder on 13 Jan 2022
The US FDA issues a complete response letter for the biologics license application for insulin aspart
7 January 2022 - The U.S. FDA has issued a complete response letter for the biologics license application for insulin ...
Posted by Michael Wonder on 26 Dec 2021
Coherus announces U.S. FDA approval of Yusimry (adalimumab-aqvh)
20 December 2021 - Approved for all eligible indications of the reference biological product, Humira (adalimumab). ...
Posted by Michael Wonder on 21 Dec 2021
Sandoz submits biologics license application for proposed biosimilar trastuzumab to US FDA
20 December 2021 - Biologics license application is supported by analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix. ...