Biosimilar Development News
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Biosimilars Forum Announces Support For Increasing Access To Biosimilars Act
3/20/2024
Bipartisan legislation introduced by U.S. Senators John Cornyn (R-TX) and Michael Bennet (D-CO) would lower prescription drug prices for seniors and promote free-market competition
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Dr. Reddy's Laboratories Launches Versavo (bevacizumab) In The UK
3/19/2024
Dr. Reddy’s Laboratories Ltd. hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company, announced the launch of Versavo (bevacizumab) in the United Kingdom (UK). Dr. Reddy’s Versavo is a (bevacizumab) biosimilar of Avastin1 and indicated for the treatment of several types of cancers, including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and
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Fresenius Kabi And Formycon Reach Settlement Agreement For Ustekinumab Biosimilar Candidate
3/18/2024
Fresenius Kabi and Formycon announced today that they have reached a settlement agreement with Johnson & Johnson for FYB202, a proposed ustekinumab biosimilar to Stelara in Europe and Canada. The terms of the settlement are confidential.
- Bio-Thera Solutions Partners With Steincares To Market Two Biosimilars In LATAM 3/18/2024
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Phase 3 Clinical Trial Completed In China For Boan Biotech’s Dulaglutide Injection BA5101. BLA To Be Filed Soon
3/15/2024
Boan Biotech today announced the completion of a Phase 3 clinical trial (a comparative study of efficacy, safety, and immunogenicity) for its Dulaglutide Injection (BA5101) in China and the plan to submit a Biologics License Application (BLA) for the drug. The investigational drug is a biosimilar of Trulicity for glycemic control in adults with type 2 diabetes.
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Biosimilars Forum Urges Congress To Support Free Market Competition And Lower Prescription Drug Prices For Patients By Reforming Pharmacy Benefit Managers
3/15/2024
Juliana M. Reed, executive director the Biosimilars Forum, released the following statement following a press conference by Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho. The two Senators urged their conferences to pass Pharmacy Benefit Manager (PBM) reform.
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Biocon Biologics Enters A Long-Term Commercial Collaboration With Eris Lifesciences To Expand Patient Access In India
3/14/2024
Biocon Biologics Limited, a fully integrated global biosimilars company and a subsidiary of Biocon Limited, today announced a long -term commercial collaboration with Eris Lifesciences to expand patient access to its portfolio of Metabolics, Oncology, and Critical Care products in India.
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Celltrion USA Completes Submission Of Biologics License Application (BLA) To U.S. FDA For CT-P39, An Interchangeable Biosimilar Candidate Of XOLAIR® (omalizumab)
3/10/2024
Celltrion USA today announced that the company has submitted a Biologics License Application (BLA) for CT-P39, an interchangeable biosimilar candidate to XOLAIR® (omalizumab) to the U.S. Food and Drug Administration (FDA).[1]
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Samsung Bioepis Presents Two Abstracts For Its Immunology Portfolio At The 2024 American Academy Of Dermatology (AAD) Annual Meeting
3/9/2024
Samsung Bioepis Co., Ltd. presented two new study results for its immunology portfolio – SB5, a biosimilar to Humira1 (adalimumab), and SB17, a proposed biosimilar to Stelara2 (ustekinumab) – at the 2024 American Academy of Dermatology (AAD) Annual Meeting being held from March 8 to 12 in San Diego, California, United States.
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Fresenius Kabi’s Biosimilar Tyenne (tocilizumab-aazg) Becomes The First IV And Subcutaneous Tocilizumab Biosimilar Approved By The FDA
3/7/2024
Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Tyenne* (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra** (tocilizumab). Tyenne becomes the first tocilizumab biosimilar with both IV and subcutaneous formulations approved by the FDA.