Blog
RSS FeedPosted by Michael Wonder on 05 Sep 2020
Biocon, Mylan launch Semglee and seek biosimilar, interchangeable status
31 August 2020 - For all intents and purposes, Semglee is a biosimilar insulin, but official biosimilar status is needed to ...
Posted by Michael Wonder on 18 Jul 2020
Why biosimilar approval applications break down
17 July 2020 - Investigators found that process complexities have created numerous difficulties for biosimilar developers in regulatory filings, but ...
Posted 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 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 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 12 May 2020
Investigators propose different measures for biosimilar equivalence
12 May 2020 - Investigators use the HERITAGE trial findings to argue for a more precise way of measuring clinical equivalence ...
Posted by Michael Wonder on 05 May 2020
Teva and Celltrion Healthcare announce the launch of Truxima (rituximab-abbs) injection for rheumatoid arthritis, the only biosimilar to Rituxan (rituximab) available in the United States for this indication
4 May 2020 - Truxima is also now available for the treatment of granulomatosis with polyangiitis (Wegener’s granulomatosis) and microscopic polyangiitis. ...
Posted by Michael Wonder on 15 Apr 2020
Merck announces US launch of Ontruzant (trastuzumab-dttb), a biosimilar of Herceptin (trastuzumab)
15 April 2020 - Merck today announced the U.S. launch of Ontruzant (trastuzumab-dttb), as a biosimilar of the reference biologic ...
Posted by Michael Wonder on 02 Apr 2020
Biosimilars could disappear if the Supreme Court overturns the ACA
1 April 2020 - With the sense of urgency rightly focused on slowing or stopping the spread of COVID-19, it ...
Posted by Michael Wonder on 24 Mar 2020
Samsung Bioepis announces FDA approval of 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb)
24 March 2020 - 150 mg and 420 mg vial of Ontruzant are now approved. ...
Posted by Michael Wonder on 17 Mar 2020
Teva and Celltrion Healthcare announce U.S. availability of Herzuma (trastuzumab-pkrb) for injection
16 March 2020 - Teva Pharmaceuticals USA and Celltrion Healthcare today announced that Herzuma (trastuzumab-pkrb) for Injection, a biosimilar to Herceptin, ...
Posted by Michael Wonder on 09 Mar 2020
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar bevacizumab for review
9 March 2020 - Biocon and Mylan today announced that the U.S. FDA has accepted Mylan’s biologics license application for ...
Posted by Michael Wonder on 08 Mar 2020
Five years on, biosimilars need support from all health care players
6 March 2020 - Today marks a milestone for the U.S. biosimilar market: the FDA approved our first biosimilar, Sandoz’s ...