Blog
RSS FeedPosted by Michael Wonder on 23 May 2022
'EMA's refusal to authorise Herceptin biosimilar unfair'
23 May 2022 - Prestige BioPharma's recent failure to get European approval for its Herceptin biosimilar could have resulted from ...
Posted by Michael Wonder on 20 May 2022
Viatris and Biocon Biologics launch Abevmy (bevacizumab), their third oncology siosimilar, in Canada
19 May 2022 - Viatris and Biocon Biologics announced today that Abevmy (bevacizumab) is now available in Canada. ...
Posted by Michael Wonder on 17 May 2022
United Kingdom MHRA grants marketing authorisation for FYB201, Formycon's biosimilar for Lucentis
17 May 2022 - Formycon and its license partner Bioeq announce that today the MHRA has granted marketing authorisation in the ...
Posted by Michael Wonder on 16 May 2022
Pfizer settles two lawsuits, starts another over etanercept biosimilar in Australia
17 May 2022 - After agreeing to settle with Amgen over its oncology biosimilars, Pfizer issued a new patent lawsuit ...
Posted by Michael Wonder on 16 May 2022
Korea clears permit for Samsung Bioepis’ Lucentis biosimilar after US
16 May 2022 - Samsung Bioepis received marketing approval for Amelivu (ranibizumab), a biosimilar referencing Lucentis to treat various eye ...
Posted by Michael Wonder on 19 Apr 2022
Prioritising reference products over biosimilars led to millions of missed savings for Part D
20 April 2022 - Medicare Part D plans missed out on between $84 million and $143 million in savings by ...
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 08 Apr 2022
TGA approved Yuflyma
8 April 2022 - The TGA has approved yet another adalimumab biosimilar. ...
Posted by Michael Wonder on 04 Apr 2022
Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
1 April 2022 - Celerity Pharmaceuticals Uses Biocon Biologics’ Insulin Drug Substance to Develop the Product. ...
Posted by Michael Wonder on 21 Mar 2022
China’s NMPA grants greater access to rheumatology biosimilars
22 March 2022 - Since the start of 2022, China’s National Medicinal Products Agency has made strides to increase greater ...
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 10 Mar 2022
Health Canada approves Samsung Bioepis and Biogen’s Byooviz (SB11), Lucentis biosimilar (ranibizumab)
10 March 2022 - Byooviz becomes the first Lucentis biosimilar to be approved in Canada following its approval in Europe and ...
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 ...