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RSS FeedPosted 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. ...
Posted by Michael Wonder on 22 Mar 2023
Techdow USA announces FDA approval of generic Lovenox (enoxaparin sodium – preservative free) in pre-filled syringes
20 March 2023 - Techdow today announced the FDA approval of enoxaparin sodium (preservative free) in pre-filled syringes for the US ...
Posted by Michael Wonder on 02 Mar 2023
FDA and FTC collaborate to advance competition in the biologic marketplace
2 March 2023 - In 2021 alone, the US spent $256 billion on biologics. Although biologics comprise approximately 3% of prescriptions ...
Posted by Michael Wonder on 27 Feb 2023
Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma (CT-P17), in the US, saying there were some problems, but they have been solved now
24 February 2023 - Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma ...
Posted by Michael Wonder on 16 Feb 2023
Stimufend (pegfilgrastim-fpgk) now available in the United States
16 February 2023 - Fresenius Kabi introduces its first biosimilar in the US. ...
Posted by Michael Wonder on 15 Feb 2023
Henlius announces US FDA acceptance of biologics license application for proposed biosimilar trastuzumab HLX02
14 February 2023 - The first Chinese biosimilar approved in both China and the EU, and potentially to be approved in ...
Posted by Michael Wonder on 06 Feb 2023
Sandoz biologics license application for proposed biosimilar denosumab accepted by US FDA
6 February 2023 - Submission supported by comprehensive analytical and clinical data package. ...