News and Press Releases
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
Johnson & Johnson receives CHMP positive opinion for AKEEGA (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations
AMPLITUDE is the first clinical trial to evaluate potential therapies for patients with mHSPC and known HRR gene alterations, with positive results supporting the niraparib-based combination regimen as a new standard...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2026
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
ALK receives positive CHMP opinion for EURneffy 1mg (nasal adrenaline spray) for emergency anaphylaxis treatment in children (≥15kg)
30 January 2026 -- Hørsholm – Denmark -- Today ALK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a...
Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: January 30, 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
Dawnzera (donidalorsen) granted European Union marketing authorisation for the prevention of hereditary angioedema
Donidalorsen is a first-in-class RNA-targeted prophylactic therapy for patients with hereditary angioedema (HAE) Donidalorsen demonstrated a significant reduction in HAE attack rate compared with placebo in the Phase 3 OASIS-HAE...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 21, 2026
Gallions Wexham Springs Framewood Road Wexham SL3 6PJ
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
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
The Charter Building, Vine Street, Uxbridge, Middlesex, United Kingdom, UB8 1JG
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
Lonza’s Synaffix Collaborates with Qurient Therapeutics to Enable Development of Dual-Payload ADC
License agreement centered around technology enabling dual-payload ADC Unique combination of Synaffix’s exatecan-based technology with Qurient’s CDK7 inhibitor. 25 September 2025 -- Amsterdam, The Netherlands and Seongnam-Si, Korea -- Synaffix B.V.,...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: September 25, 2025
Pivot Park, Curie Building Kloosterstraat 9 5349 AB Oss The Netherlands
