Biosimilar Development News
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Henlius Announces Successful Completion Of Phase 1 PK Similarity Clinical Study Of Denosumab HLX14
2/1/2024
Shanghai Henlius Biotech, Inc. (2696.HK) announced that a phase 1 clinical trial of the company’s denosumab biosimilar HLX14, a recombinant anti-RANKL human monoclonal antibody injection, met its primary endpoint.
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rBIO Completes Analytical Characterizations Of R-biolin, Readies Biosimilar Insulin Drug For Clinical Trial
2/1/2024
rBIO Co., an emerging biotechnology company dedicated to reducing the cost of life-saving medicines, has successfully completed all required analytical characterizations of its insulin biosimilar, R-biolin.
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Sandoz Launches First And Only Biosimilar For Multiple Sclerosis, Tyruko® (natalizumab), In Germany
1/31/2024
Sandoz, the global leader in generic and biosimilar medicines, today announces the launch of Tyruko® (natalizumab) in Germany from February 1. Developed by Polpharma Biologics, Tyruko® is the first and only biosimilar to treat RRMS.
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Alvotech Announces Positive Top-Line Results From A Pharmacokinetic Study For AVT03, A Proposed Biosimilar For Prolia®And Xgeva®
1/29/2024
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic (PK) study for AVT03, a biosimilar candidate to Prolia® and Xgeva®, which both contain denosumab.
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Celltrion USA Completes Submission Of Biologics License Application For CT-P47, A Biosimilar Candidate Of ACTEMRA® (tocilizumab)
1/28/2024
Celltrion USA today announced the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product ACTEMRA® (tocilizumab)[1].
- Biosimilars Forum Welcomes Teva As Newest Member 1/24/2024
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Sandoz Announces Agreement To Acquire CIMERLI® Business From Coherus, Strengthening Position In US Market
1/22/2024
Sandoz, the global leader in generic and biosimilar medicines, has signed an agreement to acquire the US biosimilar ranibizumab CIMERLI®* (ranibizumab-eqrn) from Coherus BioSciences, Inc. for an upfront cash purchase payment of USD 170 million.
- Xbrane Announces A Preferential Issue Of Units Of Approximately SEK 343 Million 1/22/2024
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Alvotech Provides Update On Status Of Biologics License Applications For AVT02 And AVT04
1/19/2024
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the reinspection of Alvotech’s facility in Iceland by the U.S. Food and Drug Administration (FDA) which started on January 10, 2024, has been concluded.
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Boan Biotech Obtains ANVISA GMP Certification
1/18/2024
Boan Biotech announced today that it has received GMP certification from the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) for its biological product, Boyuno (Bevacizumab Injection), covering the drug substance and the drug product.