Biosimilar Development News
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Charting New Paths: Non-TNF's Evolving In Rheumatoid Arthritis Market
2/23/2024
Amidst the array of advanced treatment avenues available for rheumatoid arthritis (RA), ranging from legacy TNF inhibitors and their newer biosimilar counterparts, JAK inhibitors, and various biologics with alternate mechanisms of action (MOA), the ongoing necessity for patients to transition between therapies prompts rheumatologists to seek innovative pathways towards ensuring optimal patient care.
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Samsung Bioepis Presents Two Abstracts For SB17, A Proposed Biosimilar To Stelara (Ustekinumab), At The 19th Annual Congress Of European Crohn’s And Colitis Organisation (ECCO)
2/22/2024
Samsung Bioepis Co., Ltd. today announced that two new study results for SB17, a proposed biosimilar to Stelara (ustekinumab),will be presented at the 19th Congress of European Crohn’s and Colitis Organisation (ECCO) being held from February 21 to 24 in Stockholm, Sweden.
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Polpharma Biologics' Investigational Biosimilar Shows PK/PD Comparability To Inflammatory Bowel Disease Blockbuster Entyvio®
2/21/2024
Polpharma Biologics, an international biotech company dedicated to the development and manufacturing of biosimilars, today announced topline results demonstrating the pharmacokinetic (PK) and pharmacodynamics (PD) comparability of its biosimilar candidate PB016 to its reference drug, Entyvio®* (vedolizumab).
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Samsung Bioepis Initiates Phase 1 Clinical Trial For SB27, Proposed Biosimilar To Keytruda (Pembrolizumab)
2/21/2024
Samsung Bioepis Co., Ltd. today announced the initiation of Phase 1 clinical trial for SB27, the company's proposed biosimilar referencing Keytruda (pembrolizumab).
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Coherus Announces U.S. Launch Of UDENYCA ONBODY™ A Novel And Proprietary State-Of-The-Art Delivery System For pegfilgrastim-cbqv
2/21/2024
Coherus BioSciences, Inc. (Coherus, NASDAQ: CHRS) today announced the launch of UDENYCA ONBODY™, the company's on-body injector (OBI) presentation of UDENYCA® (pegfilgrastim-cbqv), is successfully underway, with a broad distribution of accounts nationwide ordering this innovative device, and patients now accessing its benefits.
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Organon Announces HADLIMA (adalimumab-bwwd) Has Been Exclusively Selected By The US Department Of Veterans Affairs (VA), Replacing HUMIRA On Its National Formulary
2/20/2024
Organon, a global healthcare company with a dedicated commitment to biosimilars, announced that the US Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary.
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Sandoz Receives Health Canada Approval For Jubbonti®, First And Only denosumab Biosimilar For Treatment Of Osteoporosis
2/20/2024
Sandoz Canada is pleased to announce that Health Canada has provided authorization to market Jubbonti® (denosumab subcutaneous injection, reference medicine: Prolia*).
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Alvotech Announces Expected Global Market Entry Dates For AVT04 Biosimilar To Stelara® (ustekinumab)
2/15/2024
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has reached settlement agreements with Johnson & Johnson in Japan, Canada and in the European Economic Area (EEA) for AVT04, a biosimilar to Stelara® (ustekinumab).
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Biocon Biologics Partners With Sandoz Australia For Biosimilars Trastuzumab And Bevacizumab
2/8/2024
Biocon Biologics Ltd (BBL), a fully integrated biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced a five-year partnership with Sandoz AG ('Sandoz') which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD$35 million1) and biosimilar Bevacizumab (market value of AUD$45 million2) in Australia.
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Novo Holdings To Acquire CDMO Catalent Pharma Solutions For $16.5 Billion
2/5/2024
Catalent, Inc. (NYSE: CTLT), a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings, a holding and investment company that is responsible for managing the assets and wealth of the Novo Nordisk Foundation, today announced that they have entered into a merger agreement under which Novo Holdings will acquire Catalent in an all-cash transaction that values Catalent at $16.5 billion on an enterprise value basis.