News and Press Releases

Samsung Bioepis Reaches Settlement Agreement for Eylea (Aflibercept) Biosimilar in Europe and the Rest of the World

30 January 2026 -- Incheon, Korea -- Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Regeneron and Bayer concerning the commercialization of SB15, a biosimilar to...

Category: Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2026

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Samsung Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference

Samsung Bioepis plans to secure 20 biosimilars in its products and pipeline by 2030 The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab, in addition to...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 15, 2026

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AskBio Announces FDA Acceptance of Investigational New Drug (IND) Application for AB-1009 Gene Therapy for Treatment of Late-Onset Pompe Disease (LOPD)

AB-1009 program advances to Phase 1/Phase 2; clinical trial initiated in the United States Therapy granted United States Food and Drug Administration (FDA) Fast Track and Orphan Drug designations Pompe...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 8, 2026

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Samsung Bioepis Begins Commercialization of BYOOVIZ, Biosimilar to Lucentis (Ranibizumab), in Europe

Samsung Bioepis completes full transfer of commercial rights from Biogen back to Samsung Bioepis for BYOOVIZ BYOOVIZ becomes the fourth biosimilar directly commercialized by Samsung Bioepis in Europe, following EPYSQLI...

Category: Logistics, Other, Pharmaceutical
Posted: January 2, 2026

76, Songdogyoyuk-ro, Yeonsu-gu, Incheon

Evotec-partner Bayer starts Phase 2 study for treatment of patients with Alport syndrome

Phase 2 clinical trial initiated to evaluate SEMA3A mAb as potential treatment for Alport syndrome Milestone payment to Evotec expected upon first dosing of first study participant in early 2026...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 4, 2025

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Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria

Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria Approval based on phase 3 studies showing Dupixent significantly...

Category: Drug Discovery, Other, Pharmaceutical
Posted: November 25, 2025

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Horus Pharma announces strategic Agreement to commercialize Formycon’s Aflibercept Biosimilar FYB203 under the brand name Baiama across Key European Markets including its Home Market France

23 October 2025 -- Nice, France -- Horus Pharma, the second largest independent ophthalmological laboratory in France and a leading player in Europe, today announced that it has entered into...

Category: Logistics, Other, Pharmaceutical
Posted: October 23, 2025

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IAVI, Minapharm, and ProBioGen Announce Memorandum of Understanding to Progress Clinical Development, Manufacturing, Commercialization, and Access to Vaccines and Antibodies in Africa

Partners will advance end-to-end development of biologics for regionally prioritized diseases starting with Mpox and HIV 10 October 2025 -- Cairo, Egypt; Berlin, Germany; and New York, New York -- IAVI,...

Category: Biotechnology, Drug Delivery, Logistics, Manufacturing and Packing, Other, Pharmaceutical
Posted: October 10, 2025

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Hikma and Celltrion strengthen partnership to expand biosimilar access in MENA

6 October 2025 -- London, UK -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, and its long-standing partner Celltrion Inc., a global biopharmaceutical leader, have signed exclusive licensing agreements...

Category: Logistics, Other, Pharmaceutical
Posted: October 6, 2025

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European Marketing Application for AVT23, a Proposed Biosimilar to Xolair (omalizumab), Accepted by the European Medicines Agency

6 October 2025 -- London, UK and Reykjavik, Iceland -- Advanz Pharma Holdco Limited, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: October 6, 2025

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Formycon secures U.S. License Date for proposed Aflibercept Biosimilar FYB203 following settlement and license agreement with Regeneron

Formycon and its partners entered into a settlement and license agreement with Regeneron for FYB203/AHZANTIVE (Aflibercept-mrbb) Pending litigation at the U.S. District Court for the Northern District of West Virginia...

Category: Logistics, Other, Pharmaceutical
Posted: October 2, 2025

Biocon Biologics Secures U.S. Market Entry Date for Bosaya and Aukelso, Denosumab Biosimilars

1 October 2025 -- Bengaluru, India and New Jersey, US -- Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, today announced a settlement and...

Category: Logistics, Other, Pharmaceutical
Posted: October 1, 2025

Biocon House, Semicon Park Electronics City, Phase – II, Hosur Road Bengaluru 560100, Karnataka, India

Ocugen, Inc. and Kwangdong Pharmaceutical Co., Ltd. Complete License Agreement of OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in Korea

Upfront fees and near-term development milestone payments totaling up to $7.5 million Potential sales milestones of $180 million or more in first 10 years of commercialization Royalties equaling 25% of...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: September 15, 2025

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Celltrion opens new UK headquarters in Uxbridge, UK

New office located in the heart of Uxbridge underscores Celltrion’s long-term business commitment in the UK 17 June 2025 -- London, UK -- Celltrion UK has officially opened its new...

Category: Clinical Trials, Drug Discovery, Manufacturing and Packing, Other, Pharmaceutical
Posted: June 17, 2025

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Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria

Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch and hives compared to placebo In the US, there are more than 300,000 adults and adolescents aged 12 years...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: April 18, 2025

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