Biosimilar Development News
-
Sandoz Launches Biosimilar Pyzchiva® (ustekinumab) Across Europe, To Treat Chronic Inflammatory Diseases
7/25/2024
Sandoz, the global leader in generic and biosimilar medicines, announces the launch of Pyzchiva®* (ustekinumab) across Europe, starting today.
-
Kashiv BioSciences Announces Completion Of Enrollment For Phase III Clinical Trial Of ADL018, A Biosimilar Candidate To XOLAIR (Omalizumab)
7/25/2024
Kashiv BioSciences, LLC today announced the completion of patient enrollment for its Phase III clinical trial of ADL018, a biosimilar candidate to XOLAIR®.
-
Bio-Thera Solutions Initiates Integrated Phase I / Phase III Clinical Trial For BAT3306, A Proposed Biosimilar Of Keytruda® (Pembrolizumab)
7/25/2024
Bio-Thera Solutions Inc. (688177: SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that dosing has recently begun in an integrated Phase I / Phase III clinical study for BAT3306, a proposed biosimilar of Keytruda® (pembrolizumab).
-
Bio-Thera Solutions Announces Regulatory Filing Acceptance For BAT2206, A Proposed Biosimilar To Stelara® In The US And EU
7/24/2024
Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the FDA has accepted the BLA for BAT2206, a proposed interchangeable biosimilar to Stelara® (ustekinumab) seeking a commercial license in the United States of America.
-
FDA Approves Samsung Bioepis' EPYSQLI® (eculizumab-aagh) As A Biosimilar To Soliris (eculizumab)
7/22/2024
Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for EPYSQLI® (eculizumab-aagh) as a biosimilar to Soliris1 (eculizumab).
-
STADA And Alvotech Launch Uzpruvo, The First Approved ustekinumab Biosimilar To Stelara, Across Europe
7/22/2024
STADA and Alvotech have launched Uzpruvo®, the first approved biosimilar to Stelara® in Europe, across a majority of European countries. This includes the largest markets in the region, where pricing and reimbursement approvals have been secured for market entry.
-
Boehringer Ingelheim And GoodRx Announce Exclusive Patient Affordability Initiative For Adalimumab-adbm Injection, Boehringer's Biosimilar To Humira®
7/18/2024
Boehringer Ingelheim and GoodRx (Nasdaq: GDRX), the leading prescription savings platform in the U.S., announced today a patient affordability initiative to provide citrate-free Adalimumab-adbm, Boehringer's biosimilar to Humira® (adalimumab), at a low cash price available exclusively on GoodRx.
-
Xbrane Provides Update On Its Development Portfolio
7/16/2024
Xbrane Biopharma AB (publ) ("Xbrane" or the "Company") has lately received questions regarding its development programs BIIB801 and Xdivane and hence hereby provide an update.
-
Analysis Finds Misinformation About Interchangeable Biosimilars Undermining US Health Policy, Physician Confidence, And Patient Health
7/16/2024
The Alliance for Safe Biologic Medicines (ASBM) announces the publication of a paper underscoring the critical role of the FDA's interchangeable biosimilar data requirements in maintaining the safety and efficacy of biosimilar substitutions.
-
GCCL Completes Proactive Development Of Biosimilar Clinical Trial Analysis Methods, Providing Customized Analysis Services Through Enhanced R&D Capabilities
7/16/2024
GCCL, a clinical trial sample analysis institution, has proactively developed pharmacokinetic (PK) analysis methods for blockbuster drugs' biosimilars and offers customized clinical trial analysis services for biosimilar development.