Blog
RSS FeedPosted by Michael Wonder on 09 Jul 2020
Mylan and Fujifilm Kyowa Kirin Biologics announce U.S. FDA approval of Hulio (adalimumab-fkjp)
9 July 2020 - Mylan and Fujifilm Kyowa Kirin Biologics today announced that the U.S. FDA has approved Hulio (adalimumab-fkjp), ...
Posted by Michael Wonder on 07 Jul 2020
Remove the disincentives and biosimilars will flourish, policy expert says
7 July 2020 - Patients could save as much as 17% on out-of-pocket costs if they used biosimilars, but many ...
Posted by Michael Wonder on 07 Jul 2020
Use of infliximab biosimilar in Medicare population is low but growing
7 July 2020 - Slow growth of use of biosimilar infliximab in a Medicare fee-for-service population suggests lingering hesitancy on the ...
Posted by Michael Wonder on 30 Jun 2020
First adalimumab biosimilar gains approval in Japan
30 June 2020 - Fujifilm Kyowa Kirin Biologics said it has received Japanese regulatory approval to manufacture and market the ...
Posted by Michael Wonder on 29 Jun 2020
Samsung Bioepis receives positive CHMP opinion for Aybintio (bevacizumab)
26 June 2020 - Abbintio, a biosimilar candidate referencing Avastin (bevacizumab), is Samsung Bioepis’ second oncology biosimilar to be recommended for ...
Posted by Michael Wonder on 25 Jun 2020
Sandoz Canada launches the biosimilars generation
25 June 2020 - Campaign provides needed, fact-based, information for patients, healthcare providers and Canadians about biosimilar medicines in Canada. ...
Posted by Michael Wonder on 24 Jun 2020
Looking back, UK patients unhappy with adalimumab biosimilar switch
24 June 2020 - The UK results show how challenging switching to a biosimilar can be, according to patient groups. ...
Posted by Michael Wonder on 15 Jun 2020
Rising costs explain why Canada is switching to biosimilars
15 June 2020 - Following in the footsteps of British Columbia, other Canadian provinces are working to implement their own biosimilars ...
Posted by Michael Wonder on 12 Jun 2020
Mylan and Biocon announce U.S. FDA approval of Semglee (insulin glargine injection)
11 June 2020 - FDA approval marks a significant milestone to help increase access and affordability of insulin for the millions ...
Posted by Michael Wonder on 11 Jun 2020
FDA approves Pfizer's oncology supportive care biosimilar Nyvepria (pegfilgrastim-apgf)
11 June 2020 - Pfizer today announced the United States FDA has approved Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim). ...
Posted by Michael Wonder on 10 Jun 2020
Sandoz Canada receives Health Canada approval to launch two oncology biosimilars: Ziextenzo and Riximyo
9 June 2020 - These two approvals mark an important milestone for Sandoz Canada, bringing its biosimilars into oncology at a ...
Posted by Michael Wonder on 09 Jun 2020
Mylan and Lupin receive European marketing authorisation for Nepexto, biosimilar etanercept
4 June 2020 - Mylan and Lupin today announced that the European Commission (EC) has granted marketing authorization for Nepexto, ...
Posted by Michael Wonder on 04 Jun 2020
FDA re-evaluates user fees for biosimilar reviews
4 June 2020 - Even before the pandemic, the FDA was having trouble estimating its resource needs for biosimilar application reviews. ...
Posted by Michael Wonder on 29 May 2020
FDA accepts for review Fresenius Kabi’s first biosimilar regulatory submission for MSB11455, a biosimilar candidate of pegfilgrastim
27 May 2020 - Fresenius Kabi announced today that the U.S. FDA has accepted for review the company’s biologics license ...
Posted by Michael Wonder on 26 May 2020
New biosimilar trastuzumab on the PBS - information for health professionals and patients
26 May 2020 - A biosimilar brand of trastuzumab (Trazimera) was listed on the PBS on 1 May 2020. ...