Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 23 Nov 2021
The BBB’s threat to biosimilar drug development
23 November 2021 - In 2019, longtime pharmaceutical industry critic, Peter Bach, took to the Wall Street Journal to declare that ...
Posted by Michael Wonder on 16 Nov 2021
Viatris and Biocon Biologics announce launch of interchangeable Semglee (insulin glargine-yfgn) injection and insulin glargine (insulin glargine-yfgn) injection
16 November 2021 - Branded and unbranded versions of the first-ever interchangeable biosimilar in the U.S. provide more affordable options for ...
Posted by Michael Wonder on 11 Nov 2021
FDA touts success and challenges in biosimilar development
10 November 2021 - A top official from the US FDA offered a mixed assessment of the agency’s biosimilars program, noting ...
Posted by Michael Wonder on 09 Nov 2021
FDA’s Woodcock says agency has resumed normal review pace for biosimilars, generics
9 November 2021 - Janet Woodcock, MD, acting commissioner of the FDA, delivered an upbeat report on biosimilars and generics progress ...
Posted by Michael Wonder on 18 Oct 2021
FDA approves Cyltezo, the first interchangeable biosimilar to Humira
18 October 2021 - The U.S. FDA approved the first interchangeable biosimilar product to treat certain inflammatory diseases. ...