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RSS FeedPosted by Michael Wonder on 03 Jul 2023
Organon & Samsung Bioepis announce US launch of Humira biosimilar Hadlima (adalimumab-bwwd) in multiple presentations consistent with originator
1 July 2023 - Individualised patient support program “Hadlima For You” available including co-pay support. ...
Posted by Michael Wonder on 03 Jul 2023
Cyltezo, first and only FDA approved interchangeable biosimilar to Humira, now commercially available in the US
1 July 2023 - Cyltezo is the only adalimumab biosimilar with Phase 3 comparative clinical studies in rheumatoid arthritis, plaque ...
Posted by Michael Wonder on 03 Jul 2023
Celltrion USA launches Yuflyma (adalimumab-aaty), a Humira (adalimumab) biosimilar, in the US
3 July 2023 - Celltrion USA today announced the launch of Yuflyma (adalimumab-aaty), a high concentration (100 mg/mL) and citrate-free formulation ...
Posted by Michael Wonder on 03 Jul 2023
Celltrion applies for approval in US for eye treatment biosimilar
30 June 2023 - The biopharmaceutical company now covers ophthalmology as well as auto-immune disease and cancer medicine. ...
Posted by Michael Wonder on 01 Jul 2023
Sandoz to launch Hyrimoz (adalimumab-adaz) high concentration formulation, marking Sandoz entrance into US immunology space
1 July 2023 - Hyrimoz (adalimumab-adaz) high concentration formulation biosimilar offers US patients reduced injection volume in citrate free formulation. ...
Posted by Michael Wonder on 30 Jun 2023
Formycon announces submission of the biologics license application for FYB203, an aflibercept biosimilar candidate to the US FDA
29 June 2023 - Formycon and its license partner Klinge Biopharma announce that the biologics license application for FYB203, a ...
Posted by Michael Wonder on 28 Jun 2023
Cyltezo, first interchangeable biosimilar to Humira, receives preferred formulary status with Optum Rx for commercially insured patients
23 June 2023 - Cyltezo will be commercially available in the US on 1 July 2023. ...
Posted by Michael Wonder on 21 Jun 2023
Xbrance announce US FDA filing acceptance for a Lucentis (ranibizumab) biosimilar candidate
21 June 2023 - Xbrane Biopharma today announced the acceptance of the supplemental biologics license application for a Lucentis (ranibizumab) biosimilar ...
Posted by Michael Wonder on 15 Jun 2023
Coherus resolves part of dispute with AbbVie over Humira biosimilar
16 June 2023 - Coherus BioSciences said on Thursday it had agreed to retract a restraining order against AbbVie as ...
Posted by Michael Wonder on 05 Jun 2023
Mark Cuban Cost Plus Drug Company joins forces with Coherus to make Yusimry, a Humira biosimilar, available to patients
1 June 2023 - YUSIMRY will be available on costplusdrugs.com for $569.27 plus dispensing and shipping fees. ...
Posted by Michael Wonder on 02 Jun 2023
Coherus announces industry wide lowest list price for adalimumab biosimilar Yusimry (adalimumab-aqvh) launching in July 2023
1 June 2023 - List price of $995 per carton for two 40 mg/0.8 mL auto-injectors. ...
Posted by Michael Wonder on 25 May 2023
Celltrion USA announces US FDA approval of Yuflyma (adalimumab-aaty), a high concentration and citrate free formulation of Humira (adalimumab) biosimilar
24 May 2023 - Yuflyma is FDA approved to treat eight conditions including Crohn’s disease and ulcerative colitis. ...
Posted by Michael Wonder on 23 May 2023
US FDA approves the Cyltezo Pen, a new auto-injector option, ahead of 1 July commercial launch
22 May 2023 - Cyltezo (adalimumab-adbm) will be commercially available in the US beginning on 1 July 2023. ...
Posted by Michael Wonder on 08 Apr 2023
Accord BioPharma announces US FDA acceptance of biologics license application for proposed biosimilar trastuzumab HLX02
5 April 2023 - The biosimilar for Herceptin seeks to treat several forms of HER2 cancer. ...
Posted by Michael Wonder on 22 Mar 2023
Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation
21 March 2023 - Biosimilar Hyrimoz (adalimumab-adaz) high-concentration formulation approved for seven indications of reference medicine Humira. ...