Blog
RSS FeedPosted by Michael Wonder on 17 Feb 2021
Sandoz Canada completes its fifth biosimilar launch with new biosimilar Hyrimoz (adalimumab)
16 February 2021 - Hyrimoz for use in nine indications covered by the reference medicine in the fields of rheumatology, gastro-enterology ...
Posted by Michael Wonder on 16 Feb 2021
Celltrion Healthcare receives European Commission approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, Yuflyma (CT-P17)
15 February 2021 - Yuflyma is approved in all intended indications for the treatment of multiple chronic inflammatory diseases. ...
Posted by Michael Wonder on 14 Feb 2021
Biosimilars: is interchangeability the proof of the pudding?
15 February 2021 - While apparently non‐inferior to originator biologics, other factors need to be considered before switching ...
Posted by Michael Wonder on 02 Feb 2021
Celltrion Healthcare receives Health Canada marketing authorization for world's first subcutaneous formulation of infliximab, Remsima SC, for the treatment of people with rheumatoid arthritis
1 February 2021 - This novel formulation provides an alternative administration option for Canadian physicians and their patients. ...
Posted by Michael Wonder on 28 Jan 2021
Bio-Thera Solutions announces FDA accepts biologics license application for BAT1706, a proposed biosimilar to Avastin
28 January 2021 - Bio-Thera Solutions today announced that the U.S. FDA has accepted its biologics license application for BAT1706, a ...
Posted by Michael Wonder on 07 Jan 2021
Adalimumab biosimilars face product obsolescence before launch
6 January 2021 - Product differentiation by concentration is a threat to the multiple adalimumab biosimilars approved but not yet ...
Posted 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 18 Dec 2020
Sandoz Canada receives authorisation from Health Canada to launch new biosimilar Hyrimoz (adalimumab)
17 December 2020 - Hyrimoz approved for use in all same indications as reference medicine* including rheumatology, gastro-enterology and dermatology. ...
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 10 Dec 2020
Valeo Pharma announces Health Canada approval for Redesca and Redesca Hp
9 December 2020 - Valeo Pharma announced today that Health Canada has issued a Notice of Compliance for Redesca and ...
Posted by Michael Wonder on 26 Nov 2020
Bio-Thera Solutions submits marketing authorisation application for BAT1706, a proposed biosimilar to Avastin, to European Medicines Agency
25 November 2020 - Bio-Thera Solutions today announced that it has submitted the marketing authorisation application for BAT1706, a proposed biosimilar ...
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 19 Nov 2020
Kyowa Kirin announces approval for partial change of rituximab biosimilar received by Sandoz in Japan
18 November 2020 - Kyowa Kirin today announced that Sandoz KK, its strategic partner of the anti-CD20 monoclonal antibody rituximab ...
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 ...