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RSS FeedPosted by Michael Wonder on 15 Jul 2023
European Medicine Agency accepts Intas' marketing authorisation application for DMB-3115, a proposed biosimilar to Stelara (ustekinumab)
14 July 2023 - Therapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global Phase III trial. ...
Posted by Michael Wonder on 13 Jul 2023
Dr. Reddy’s proposed rituximab biosimilar application accepted for review by US FDA, EMA and MHRA
12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review. ...
Posted by Michael Wonder on 11 Jul 2023
Express Scripts adds three biosimilars to largest formulary to promote competition and advance affordability, choices for patients
11 July 2023 - Express Scripts will include Cyltezo and both Sandoz products (Hyrimoz and unbranded adalimumab-adaz) – inflammatory disease biosimilars ...
Posted by Michael Wonder on 10 Jul 2023
Idacio (adalimumab-aacf) now available in the United States
3 July 2023 - CMS grants Fresenius Kabi permanent, product-specific Q Code for Idacio (adalimumab-aacf). ...
Posted by Michael Wonder on 09 Jul 2023
After five years of successful experience internationally, Biocon Biologics’ Hulio biosimilar to Humira, now available in the United States
3 July 2023 - Biocon Biologics today announced that Hulio (adalimumab-fkjp) injection, a biosimilar to Humira (adalimumab), is now available ...
Posted 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 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, ...