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
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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.
SEC Staff Issues New CFIs on Schedule 13D, Total Return Swaps and Proxy Rules
Securities Trading on the Newly-Launched Texas Stock Exchange
The Texas Stock Exchange (TXSE) commenced quoting and trading securities pursuant to unlisted trading privileges on July 6, 2026, and the new national securities exchange intends to commence trading of other securities on the exchange in the coming weeks. The
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
Celltrion and Teva’s TRUXIMA® Becomes First Interchangeable Rituximab Biosimilar in U.S.
On July 1, 2026, Celltrion announced that the FDA had granted interchangeability designation to TRUXIMA® (rituximab-abbs), Celltrion and Teva’s biosimilar to Genentech’s RITUXAN®. With this designation, TRUXIMA® became the first rituximab biosimilar to receive interchangeable status in the United States.
FDA Expands Indication for Vertex’s CASGEVY to Children Aged Two Years and Older
On July 1, 2026, Vertex Pharmaceuticals announced that the FDA approved an expanded indication for CASGEVY (exagamglogene autotemcel) to treat children aged two years and older with sickle cell disease (SCD) experiencing recurrent vaso-occlusive crises or who have transfusion-dependent beta