Biosimilar Development News
-
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.
-
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.
-
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]
-
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.
-
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.
-
The Cigna Group Raises Long-Term Growth Target, And Launches New Innovative Solutions At 2024 Investor Day
3/7/2024
Today, global health company The Cigna Group (NYSE:CI), will outline its growth and innovation strategies at its 2024 Investor Day. In addition, the company is raising its long-term average annual adjusted EPS1 growth target to 10%-14% and is reaffirming its 2024 adjusted EPS1 guidance of at least $28.25.
-
Sandoz Receives FDA Approval For First And Only Denosumab Biosimilars
3/5/2024
Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines.
-
WEZLANA™ (Ustekinumab), A Biosimilar To Stelara®, Now Available In Canada For Certain Chronic Inflammatory Diseases
3/4/2024
Amgen Canada today announced that WEZLANA (ustekinumab injection) and WEZLANA I.V. (ustekinumab for injection, solution for intravenous infusion), a biosimilar to STELARA, is now available in Canada.
-
Sandoz Acquires CIMERLI® Business From Coherus, Further Building Biosimilar And Ophthalmology Leadership In US Market
3/4/2024
Sandoz, the global leader in generic and biosimilar medicines, has completed the acquisition of the US biosimilar CIMERLI®* (ranibizumab-eqrn) from Coherus BioSciences, Inc, ahead of anticipated timelines.
-
Henlius Adalimumab Biosimilar Received sNDA Acceptance Notification From The NMPA
2/29/2024
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications (sNDAs) of its adalimumab biosimilar HANDAYUAN for the treatment of polyarticular juvenile idiopathic arthritis,pediatric plaque psoriasis and other indications have been accepted by the National Medical Products Administration (NMPA),bringing new hope to pediatric patients and their families.