News & Analysis as of

Joint Venture Biosimilars

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Prestige Biopharma and Intas Pharmaceuticals Partner on Bevacizumab Biosimilar

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On July 26, Prestige Biopharma Limited (“Prestige”) announced a partnership with Intas Pharmaceuticals Limited (“Intas”) and its affiliate Accord Healthcare to commercialize Prestige’s bevacizumab, HD204, a proposed...more

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Hikma and Celltrion Announce Collaboration to Market Adalimumab Biosimilar YUFLYMA in Middle East and North Africa

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On Monday, Hikma announced a partnership with Celltrion to market YUFLYMA (CT-P17) in the Middle East and North Africa. CT-P17 is a high-concentration, low-volume and citrate-free adalimumab biosimilar, indicated for the...more

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Biosimilar Partnership News

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Eris Lifesciences (“Eris”) announced its joint venture with Mumbai-based MJ Biopharm Pvt Ltd. (“MJ”),  Eris MJ Biopharm Ltd.,  focused on the marketing and distribution of insulins (including aspart, glargine and lispro),...more

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Plantform and Bio-Manguinhos/Fiocrus to Partner on Pembrolizumab Biosimilar for Brazil

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Last week, PlantForm Corporation, PlantPraxis Biotecnologia and Bio-Manguinhos/Fiocruz announced that they are entering into a research and development agreement to develop pembrolizumab, a biosimilar of Keytruda®, for the...more

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Lannett Announces New Co-development Agreement for Biosimilar Insulin Aspart

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On February 9, 2021, Lannett Company announced that it had added a new co-development agreement for biosimilar insulin aspart with its strategic alliance partners within the HEC Group of Companies. Insulin aspart, currently...more

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Biocon Biologics Expands Access to Biosimilars In Over 30 Countries In Africa and Asia

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Biocon Biologics, a subsidiary of Biocon, announced today that it has signed an agreement with Clinton Health Access Initiative (CHAI) to develop advanced cancer therapies for patients in 25 countries in Africa and 5...more

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Recent Biosimilars Deals

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On January 13, 2021, EVOQ announced a license and collaboration agreement with Amgen for the development of new drugs for autoimmune disorders. According to the press release, Amgen and EVOQ will collaborate on preclinical...more

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Lotus and CKD Announce Biosimilar Collaboration

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On September 19, 2020, Lotus Pharmaceutical Co., Ltd. (“Lotus”) and Chong Kun Dang Pharmaceutical Corp. (“CKD”) announced that they have entered into a commercialization agreement in connection with CKD’s biosimilar...more

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Bio-Thera Solutions and BeiGene Announce Agreement for the Rights to Bio-Thera’s Avastin Biosimilar BAT1706 in China

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Last week, BeiGene and Bio-Thera Solutions announced that the companies had entered into a license, distribution, and supply agreement for BAT1706, Biothera’s Avastin® (bevacizumab) biosimilar, in China. According to the...more

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TRUXIMA launches as first U.S. Rituxan® biosimilar approved for RA

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Teva and Celltrion Healthcare announced today the U.S. launch of TRUXIMA® (rituximab-abbs) for rheumatoid arthritis (RA). TRUXIMA®, which originally launched in November 2019, is now approved to treat RA, non-Hodgkin lymphoma...more

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Biosimilar Developers Comment on Regulatory Delays

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Multiple biosimilar developers recently released statements regarding potential regulatory delays facing their biosimilars or follow-on biologics. ...more

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Biosimilar and Biologic Business Developments Update – Collaborations and Licensing Deals

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Last week, Almirall signed an agreement with WuXi Biologics to collaborate on multiple bispecific antibodies targeting dermatology conditions, including atopic dermatitis. Almirall’s press release indicated that, “[u]nder the...more

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XBrane and STADA Collaborating to Develop Lucentis® Biosimilar

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Today, XBrane Biopharma and STADA Arzneimittel announced that they have entered into a co-development agreement for Xlucane, a proposed biosimilar of Lucentis® (ranibizumab), in which the companies will equally contribute and...more

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Sandoz announces collaboration with Biocon on next-generation biosimilars

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Last week, Sandoz announced a new collaboration with Asian biopharmaceutical company Biocon to “to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms...more

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EMA’s Issues Statement of Non-Compliance for Biocon’s Biosimilar Manufacturing Facility

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As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, and they have filed applications for marketing authorization in the European Union for three biosimilar products: Fulphila...more

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Celltrion Reportedly Partnering with George Steuart Health on Sri Lankan Remsima (infliximab)

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Lanka Business News is reporting that Celltrion and George Steuart Health have teamed up to launch Remsima (infliximab) in Sri Lanka...more

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Amgen and Allergan Submit BLA for Avastin® Biosimilar

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As we previously reported, Amgen and Allergan are currently collaborating on four oncology biosimilars, including an Avastin® (bevacizumab) biosimilar, ABP 215. Yesterday, the companies announced the submission of a...more

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Fujifilm Kyowa Kirin Biologics Announces Successful Adalimumab Biosimilar Trial Results

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On October 19, Fujifilm Kyowa Kirin Biologics (a joint venture between Fujifilm and Kyowa Hakko Kirin), announced successful results in the global Phase 3 study of its Humira® (adalimumab) biosimilar candidate, FKB327. ...more

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A Global Phase III Trial for Avastin Biosimilar Has Begun

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Samsung Bioepis – the joint venture between Samsung and Biogen Idec – has started a phase III clinical trial for a biosimilar version of Roche’s cancer drug Avastin (bevacizumab). Bevacizumab slows the growth of new blood...more

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