Blog
RSS FeedPosted by Michael Wonder on 27 Dec 2020
Pandemic delays FDA decision on Biocon's bevacizumab application
27 December 2020 - For Bengaluru, Karnataka, India–based Biocon Biologics, the pandemic has interrupted the FDA review process for its ...
Posted by Michael Wonder on 17 Dec 2020
FDA approves Amgen's Riabni (rituximab-arrx), a biosimilar to Rituxan (rituximab)
17 December 2020 - Fifth FDA Approval From Amgen's Biosimilars Portfolio. ...
Posted by Michael Wonder on 16 Dec 2020
In a petition, Boehringer warns FDA its definition of ‘strength’ threatens biosimilar competition
10 December 2020 - Arguing the FDA is precluding competition for biosimilar manufacturers, Boehringer Ingelheim has petitioned the agency to ...
Posted by Michael Wonder on 19 Nov 2020
Alvotech announces that the U.S. FDA and EMA have accepted regulatory submissions for AVT02, a proposed biosimilar to Humira (adalimumab)
19 November 2020 - Alvotech is developing AVT02 as a proposed biosimilar to Humira (adalimumab) with high concentration (100 mg/mL) dosage ...
Posted by Michael Wonder on 18 Nov 2020
Samsung Bioepis and Biogen announce FDA filing acceptance of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
18 November 2020 - Samsung Bioepis and Biogen today announced that the U.S. FDA has accepted for review the biologics license ...
Posted by Michael Wonder on 17 Nov 2020
Genentech files to block marketing of Centus' bevacizumab biosimilar
18 November 2020 - The reference product rights holder contends that Centus has not provided complete information about its manufacturing ...
Posted by Michael Wonder on 03 Nov 2020
Regulatory policy may not stop comparative efficacy trials
4 November 2020 - The way Sarfaraz K. Niazi, looks at it, doing comparative efficacy studies in humans to confirm that ...
Posted by Michael Wonder on 15 Oct 2020
Testing requirements are likely slowing biosimilar entries in the US
14 October 2020 - Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation ...
Posted by Michael Wonder on 12 Oct 2020
Efficacy trials cost more, take longer for biosimilars than originators
11 October 2020 - Average clinical efficacy testing cost millions of dollars more for Phase 3 biosimilar studies than for ...
Posted by Michael Wonder on 15 Sep 2020
Rep Grothman introduces bill for automatic insulin biosimilar interchangeablity
15 September 2020 - Representative Glenn Grothman, (R-Wisconsin), says interchangeability for insulins makes sense based on the savings potential and safety ...
Posted 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). ...