Celltrion has submitted a Marketing Authorization Application to the European Medicines Agency (“EMA”) for CT-P55, its biosimilar to Novartis’ COSENTYX® (secukinumab). The application covers all indications held by COSENTYX® in Europe, including plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, juvenile idiopathic arthritis, and hidradenitis suppurativa. According to Celltrion, CT-P55 has demonstrated…
On July 23, 2026, Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., announced the commercial launch of OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), FDA-approved interchangeable biosimilars to Amgen’s PROLIA® and XGEVA®, respectively. OSVYRTI® is indicated for the treatment of osteoporosis and bone loss related to hormone ablation therapy, while…
On July 24, 2026, Outlook Therapeutics, Inc. announced that the FDA approved LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (known as “nAMD” or “wet AMD”), marking the first FDA-approved ophthalmic formulation of bevacizumab in the United States. According to Outlook, bevacizumab has long been used off label…
On June 30, 2026, the U.S. Department of Health and Human Services (HHS) announced that COVID-19 Emergency Use Authorization (EUA) declarations will terminate on December 26, 2026, for medical devices and on June 29, 2027, for drugs and biological products. The declarations were established to facilitate access to unapproved medical…
Formycon AG (“Formycon”) announced its partnership with OneSource Specialty Pharma Limited (“One Source”) on July 14, 2026. OneSource, located in Bangalore, India, will complement Formycon’s biosimilar development experience with its biologics manufacturing capabilities. OneSource has an integrated biologics platform that ranges from cell line development to commercial fill-finish and five…
On July 9, 2026, Teva Pharmaceutical Industries and Samsung Bioepis announced they have entered into a license and commercialization agreement for OPUVIZ® (aflibercept), Samsung Bioepis’s biosimilar referencing Regeneron’s EYLEA®, in Canada. Under the agreement, Samsung Bioepis will remain responsible for product registration and manufacturing, while Teva Canada will lead commercialization…
On July 9, 2026, Accord BioPharma announced that the FDA approved ENNUMO (pegfilgrastim-pccg). ENNUMO references Amgen’s NEULASTA (pegfilgrastim). The FDA approved ENNUMO on May 7, 2026, for the same indications as NEULASTA: for adult and pediatric patients, to decrease the incidence of infections, as manifested by febrile neutropenia, in patients…
On July 9, 2026, Teva Pharmaceuticals International GmbH (“Teva”) and Polpharma Biologics International AG (“Polpharma Biologics”) announced a global licensing agreement under which Teva will obtain exclusive rights to commercialize Polpharma Biologics’ proposed biosimilar to Genentech’s OCREVUS (ocrelizumab), including both intravenous and subcutaneous formulations, upon regulatory approval. The companies said…
On July 1, 2026, Harrow announced the commercial launch of BYOOVIZ (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTIS (ranibizumab). BYOOVIZ was developed by Samsung Bioepis Co., Ltd. (“Samsung Bioepis”). BYOOVIZ was originally launched in the United States by Biogen in 2022. In October 2024, Biogen notified Samsung Bioepis of their decision…
On June 30, 2026, Orca Bio announced that the U.S. Food and Drug Administration (“FDA”) approved TREGZI™ for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host-free survival, in the treatment of adults with hematological malignancies. TREGZI™…