News and Press Releases
Samsung Bioepis Presents Nonclinical Data for its First Novel Antibody-Drug Conjugate Candidate SBE303 at AACR 2026
Nonclinical findings from pharmacology, pharmacokinetics, and toxicology studies support the advancement of SBE303 into clinical development with a favorable therapeutic index (TI), with its first-in-human Phase I clinical trial began...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 20, 2026
SteinCares and Shilpa Biologicals Strike into Licensing Agreement to Expand Access to Biosimilars Across Latin America
New partnership combines Shilpa Biologicals’ development and manufacturing capabilities with SteinCares’ regional commercialization platform Collaboration aims to expand patient access to cost-effective treatments and reinforces SteinCares’ leadership in biosimilars across...
Category: Biotechnology, Manufacturing and Packing, Other
Posted: March 10, 2026
STADA and Bio-Thera receive European Marketing Authorization for Gotenfia, a Biosimilar to Simponi
European Commission grants approval for Gotenfia, a golimumab biosimilar to Simponi that was developed by Bio-Thera and will be marketed by STADA Launch preparations are underway to bring the second...
Category: BioManufacturing, Drug Discovery, Manufacturing and Packing, Other, Pharmaceutical
Posted: February 13, 2026
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
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
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
Eisai presents 4-year Leqembi (lecanemab) open-label extension data from post-hoc sub-group analysis at German neurology congress
Clarity AD open-label extension data show that after four years of continuous lecanemab treatment in apolipoprotein E ε4 (ApoE ε4*) non-carriers and heterozygotes, patients continued to accrue benefit relative to...
Category: Clinical Trials, Other, Pharmaceutical
Posted: November 12, 2025
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
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
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
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
Capital House, 1st Floor, 85 King William Street, London EC4N 7BL
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
Leqembi (lecanemab) long-term 36-month open-label extension data from post-hoc sub-group analysis of ApoE ε4 non-carriers and heterozygotes presented at Alzheimer’s disease congress in Switzerland
Clarity AD open-label extension data show three years of continuous lecanemab treatment in apolipoprotein E ε4 (ApoE ε4) non-carrier and heterozygote patients continued to accrue benefit relative to the Alzheimer's...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: September 29, 2025
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
