Blog
RSS FeedPosted 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 15 Jun 2023
Sandoz introduces Act4Biosimilars Action Plan to accelerate patient access to biosimilar medicines
15 June 2023 - Despite nearly 20 years of availability, biosimilars show worldwide adoption rate of only 14% in initiative-tracked countries, ...
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 01 Jun 2023
Samsung Bioepis obtains European Commission approval for Soliris biosimilar
30 May 2023 - Samsung Bioepis said that the European Commission has granted marketing authorization for Epysqli, a biosimilar referencing ...
Posted by Michael Wonder on 25 May 2023
Sandoz marketing authorisation applications for proposed biosimilar denosumab accepted by EMA
25 May 2023 - Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and ...
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 26 Apr 2023
Celltrion seeks approval for Xolair biosimilar in EU
25 April 2023 - Celltrion said it has completed a marketing authorization application for CT-P39, a biosimilar referencing Xolair (omalizumab) ...
Posted by Michael Wonder on 12 Apr 2023
ASCO policy statement on biosimilar and interchangeable products in oncology
12 April 2023 - Given the current market dynamics and the regulatory landscape, this ASCO manuscript now seeks to propose several ...