Biosimilar Development News
-
Be The Most Trusted Biotech Company
5/16/2024
From June 3-6, 2024, the 2024 Biotechnology Innovation Organization International Convention (“BIO 2024”) will be held in San Diego Convention Center, California, USA.
-
Boehringer Ingelheim Expands Access To Adalimumab-adbm Injection, The Company's Biosimilar To Humira®
5/13/2024
Boehringer Ingelheim announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer's biosimilar to Humira® (adalimumab), in the U.S.
-
Xbrane And Stada Partner With Valorum Biologics To Commercialize Ranibizumab Biosimilar Candidate In The US
5/10/2024
Partners Xbrane and STADA license US commercial rights to ranibizumab to Valorum, a biosimilar commercialization specialist established by industry leaders to more efficiently sell and market biosimilars in the US. Valorum will pay a license fee of up to US$45M, plus royalties on net product sales.
-
mAbxience Appoints Jurgen Van Broeck As New CEO
5/9/2024
mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, is pleased to announce the appointment of Jurgen Van Broeck as Chief Executive Officer. Jurgen, who has served as Global Commercial Director since June 2023, brings a great deal of experience and a proven track record in the pharmaceutical and biosimilars industries.
-
Celltrion USA's adalimumab-aaty Biosimilar To HUMIRA® Now Available At Low Wholesale Acquisition Cost
5/9/2024
Celltrion USA announced today that adalimumab-aaty, the company's high-concentration (100 mg/mL) and citrate-free formulation biosimilar to HUMIRA ® (adalimumab), is now available at a low wholesale acquisition cost (WAC).
-
Rani Therapeutics To Present Clinical And Preclinical Data On Oral Delivery Of An Ustekinumab Biosimilar Via The RaniPill® Capsule At Digestive Disease Week 2024
5/9/2024
Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced that it will present clinical and preclinical and data on the RaniPill® capsule, the company’s oral delivery platform, at Digestive Disease Week® (DDW) taking place both virtually and in-person on May 18-21, 2024 in Washington, DC.
-
Biosimilars Canada Announces Re-Election Of Board Chair And Vice-Chair
5/7/2024
Biosimilars Canada is pleased to announce the unanimous re-election of Mr. Mike Woolcock, Senior Vice President of Biosimilars and Specialty Products with Apotex, as Chair of the Biosimilars Canada Board.
-
Xbrane Provides Regulatory Update On FDA Review Of Its Ranibizumab Biosimilar Candidate
5/2/2024
Xbrane Biopharma AB (“Xbrane”), a leading Swedish biosimilar developer, announce that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company’s Biologics License Application (BLA) for its ranibizumab biosimilar candidate (development name Xlucane) for treatment of retinal disorders.
-
US FDA Approves High-Concentration, Citrate-Free Formulation Of Cyltezo® (adalimumab-adbm) Injection, Boehringer Ingelheim's Interchangeable* Biosimilar To Humira®
5/1/2024
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm), the company's interchangeable* biosimilar to Humira® (adalimumab), to treat multiple chronic inflammatory diseases.
-
Sandoz Reaches Agreement With Amgen Resolving All Patent Litigation Related To Its US Denosumab Biosimilars
4/30/2024
Sandoz, the global leader in generic and biosimilar medicines, today announced that it has reached agreement with Amgen to resolve all patent disputes between the two companies relating to the US Food and Drug Administration (FDA)-approved Sandoz denosumab biosimilars.