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
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Accord BioPharma Launches OSVYRTI® and JUBEREQ® Denosumab Biosimilars
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
Outlook Therapeutics Secures FDA Approval for LYTENAVA™
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.
HHS Sets Timeline to End COVID-19 Emergency Use Authorizations
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.
Formycon and OneSource Specialty Pharma Partner to Manufacture Biosimilars
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
Teva and Samsung Bioepis Enter Into Commercialization Agreement for OPUVIZ in Canada
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
Accord BioPharma Announces FDA Approval of Pegfilgrastim Biosimilar
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
Teva and Polpharma Biologics Announce Global Licensing Agreement for Ocrelizumab Biosimilar for Multiple Sclerosis
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
Harrow Re-Launches BYOOVIZ (ranibizumab-nuna) in the United States
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.
FDA Approves Orca Bio’s TREGZI for Allogeneic Hematopoietic Transplants
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