Biosimilar Development News
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Dr. Reddy's Enters Into Collaboration With Henlius For Commercialization Of HLX15 (daratumumab), A Biosimilar Candidate To Darzalex & Darzalex Faspro In The U.S., And Europe
2/6/2025
Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd., along with its subsidiaries hereafter referred to as “Dr. Reddy’s”), today announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. related to the development and commercialization of HLX15, Henlius’s investigational daratumumab biosimilar candidate to Darzalex & Darzalex Faspro.
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US FDA Accepts Biologics License Application (BLA) For HLX11, Biosimilar Candidate Of Perjeta (pertuzumab)
2/2/2025
Shanghai Henlius Biotech, Inc. announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX11, an investigational biosimilar of Perjeta (pertuzumab).
- U.S. FDA Approves Celltrion's AVTOZMA® (tocilizumab-anoh), A Biosimilar To ACTEMRA® 1/30/2025
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Kashiv Biosciences Announces Successful Phase 1 Results For Abatacept Biosimilar Candidate, KSHB002
1/28/2025
Kashiv Biosciences, LLC, a global leader in biopharmaceutical innovation, today announced that their abatacept biosimilar candidate, KSHB002, has successfully met the primary endpoints in its Phase 1 clinical trial.
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Alvotech And Teva Announce Filing Acceptance Of U.S. Biologics License Applications For AVT05, A Proposed Biosimilar To Simponi® And Simponi Aria® (golimumab)
1/27/2025
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab), which are prescribed to treat a variety of inflammatory conditions.
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Formycon Receives EU Approval For FYB203 (Aflibercept), A Biosimilar To Eylea, Under The Brand Names AHZANTIVE And Baiama
1/21/2025
Formycon AG and its licensing partner Klinge Biopharma GmbH (“Klinge”) today jointly announce that the European Commission has granted central marketing authorization for FYB203 (Aflibercept), a biosimilar to Eylea, under the brand names AHZANTIVE and Baiama.
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Tanvex BioPharma Completes Acquisition Of Bora Biologics, Launching New Era In Biologics Development
1/20/2025
Tanvex BioPharma, Inc. ("Tanvex"), a contract development and manufacturing organization (CDMO) for biologics and a biosimilars products company, is pleased to announce the successful completion of its acquisition of Bora Biologics Co., Ltd. ("Bora Biologics"), a subsidiary of Bora Pharmaceuticals. Following this acquisition, Tanvex's CDMO services will operate under the name Bora Biologics, continuing to be owned by Tanvex.
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Sandoz To Confirm Strategic Roadmap And Highlight Pipeline Catalysts At 43rd Annual J.P. Morgan Healthcare Conference
1/14/2025
Sandoz, the global leader in generic and biosimilar medicines, will confirm its strategic roadmap and highlight pipeline catalysts in a presentation today at the 43rd Annual J.P. Morgan Healthcare Conference, taking place from January 13 to 16 in San Francisco.
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Henlius Broadens Access To Multiple Biologics In Emerging Markets
1/13/2025
Shanghai Henlius Biotech, Inc. today announced it has entered into product license and supply agreement with Abbott, granting it exclusive or semi-exclusive licenses for the commercialization of four self-developed biosimilars and one innovative biologic in 69 emerging markets in Asia, Latin America and the Caribbean, as well as Middle East and Africa.
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Teva Announces Collaboration To Commercialize Formycon's Biosimilar Candidate To Eylea® (aflibercept) In Major Parts Of Europe And In Israel
1/13/2025
Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) today announced that it has entered into a strategic collaboration with Klinge Biopharma GmbH (Klinge) and Formycon AG (FSE: FYB) for the semi-exclusive commercialization of FYB203, Formycon's biosimilar candidate to Eylea® (aflibercept) in Europe, excluding Italy, and in Israel.