Key Biosimilars Events of July 2026 

Shots:  July 2026 witnessed strong momentum across the biosimilars landscape with major regulatory approvals, including Ennumo (US FDA), Garzulys (US FDA), Yesintek Autoinjector (Health Canada), and FDA/EMA acceptance of PB016, alongside commercial launches of Byooviz, Osvyrti, and Jubereq, expanding treatment options across oncology, ophthalmology, immunology, osteoporosis, diabetes, and inflammatory diseases.   Strategic collaborations and licensing agreements between Orion Pharma–Shilpa Biologicals, Polpharma–Teva, Samsung Bioepis–Teva, Formycon–OneSource Specialty Pharma, and Organon–Samsung Bioepis strengthened global biosimilar development, manufacturing, commercialization, and market access across Europe, North America, Australia, and other international markets.   Clinical and commercial progress continued with first patient dosing of HLX15-SC, HLX18, and HLX05-N, interim Phase IV data for SB11, and expanded commercialization initiatives for multiple biosimilars, underscoring continued innovation and global expansion of the biosimilars market.  Samsung Bioepis and Harrow Relaunch Byooviz (Biosimilar, Lucentis) in the US                 Company: Samsung Bioepis and Harrow                   Product: Byooviz                 Active Ingredient: Ranibizumab                 Reference Product: Lucentis                 Reference Product Company: Genentech                 Disease: All Approved Indications                 Date: Jul 01, 2026                 Shots:  Samsung Bioepis, in partnership with Harrow, has relaunched Byooviz, a biosimilar to Lucentis (ranibizumab), in the US  Byooviz was initially commercialized by Biogen beginning in Jun 2022, before Biogen returned the US commercial rights to Samsung Bioepis at the end of 2025  Approved by the FDA in 2021 as the first ophthalmology biosimilar, Byooviz treats wet Age-Related Macular Degeneration, Macular Edema following Retinal Vein Occlusion, & Myopic Choroidal Neovascularization, & received interchangeability designation in 2023  Orion Pharma Expand Partners with Shilpa Medicare for Nivolumab Biosimilar in the EU                 Company: Orion Pharma and Shilpa Medicare                 Product: Nivolumab                 Active Ingredient: Nivolumab                 Reference Product: Opdivo                 Reference Product Company: BMS                 Disease: All Approved Indications                 Date: Jul 06, 2026                 Shots:  Orion Pharma has entered into an agreement with Shilpa Biologicals to co-develop and supply IV nivolumab biosimilar, across Europe  As per the deal, Orion will gain exclusive rights to register, market, distribute & sell the nivolumab biosimilar across EU, while Shilpa Biologicals will lead product development, exclusively manufacture & supply the product, and receive development & regulatory milestone payments along with long-term supply revenue  Nivolumab is a PD-1 immune checkpoint inhibitor that restores anti-tumor immune response by harnessing the body’s immune system for the treatment of multiple cancers  Henlius Reports First Patient Dosing in P-I Trial of HLX05-N (Biosimilar, Erbitux) in China                 Company: Henlius                 Product: HLX05-N                 Active Ingredient: Cetuximab                 Reference Product: Erbitux                 Reference Product Company: Eli Lilly                 Disease: Metastatic Colorectal Cancer                 Date: Jul 08, 2026                 Shots:  Henlius has dosed the first patient in China in the P-I HLX05-N ((HLX05-N-mCRC102), a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC)  The study will compare HLX05-N vs. US & EU sourced Erbitux in mCRC, evaluating PK similarity, efficacy, safety, and immunogenicity in combination with mFOLFOX6 CT  HLX05-N is Henlius’ cetuximab biosimilar candidate, developed under global biosimilar guidelines, with analytical and non-clinical studies demonstrating high similarity to reference cetuximab  Polpharma and Teva Sign Exclusive Licensing Deal for a Biosimilar Candidate to Ocrevus                 Company: Polpharma and Teva                   Product: Ocrelizumab                 Active Ingredient: Ocrelizumab                 Reference Product: Ocrevus                 Reference Product Company: Genentech                 Disease: All Approved Indications                 Date: Jul 09, 2026                 Shots:  Polpharma has granted Teva exclusive rights to commercialize both IV & SC formulations of Polpharma’ proposed biosimilar to Ocrevus (ocrelizumab) for multiple sclerosis, upon regulatory approval  As per the deal, Polpharma will lead biosimilar development & manufacturing, while Teva will oversee regulatory filings & commercialization across the US, EU, Brazil, Canada, Australia, New Zealand, Israel, & Turkey  Ocrelizumab is a humanized monoclonal antibody that targets CD20-positive B cells involved in the autoimmune activity associated with multiple sclerosis  Samsung Bioepis Partners with Teva to Commercialize Opuviz  (Biosimilar, Eylea) in Canada                 Company: Samsung Bioepis and Teva                 Product: Opuviz                 Active Ingredient: Aflibercept                   Reference Product: Eylea                 Reference Product Company: Bayer                 Disease: All Approved Indications                 Date: Jul 09, 2026                 Shots:  Samsung Bioepis & Teva have entered into a license and commercialization agreement to commercialize Opuviz (Biosimilar, Eylea) in Canada  As per the deal, Samsung Bioepis will be responsible for the registration & manufacture of the products, while Teva Canada will hold commercialization rights  Opuviz was approved by Health Canada in October 2025 for wet AMD, CRVO/BRVO-related macular edema, DME, and mCNV. Samsung Bioepis’ aflibercept biosimilar is also marketed in EU and South Korea  The US FDA Approves Accord BioPharma’s Ennumo (Biosimilar, Neulasta)                 Company: Accord BioPharma                 Product: Ennumo                   Active Ingredient: Pegfilgrastim                 Reference Product: Neulasta                 Reference Product Company: Amgen                 Disease: All Approved Indications                 Date: Jul 09, 2026                 Shots:  The US FDA has approved Ennumo, a biosimilar to Neulasta (pegfilgrastim), expanding Accord’s biosimilar portfolio & supporting its goal to launch 20 biosimilars in the US by 2030  Ennumo is approved for adults & pediatric pts (newborn & older) to reduce incidence of infection in febrile neutropenia in non-myeloid malignancies receiving myelosuppressive anti-cancer drugs & to improve survival following myelosuppressive radiation exposure (Hematopoietic Subsyndrome of Acute Radiation Syndrome)  Pegfilgrastim is a recombinant granulocyte colony-stimulating factor (G-CSF) that stimulates neutrophil production to reduce febrile neutropenia & infection risk following myelosuppressive CT  Henlius Reports First Patient Dosing in P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro) in the US                 Company: Henlius                   Product: HLX15-SC                 Active Ingredient: Daratumumab and Hyaluronidase-fihj                 Reference Product: Darzalex Faspro                 Reference Product Company: J&J                 Disease: Newly Diagnosed Multiple Myeloma                 Date: Jul 13, 2026                 Shots:  Henlius has dosed the first U.S. patient in the global P-I HLX15-SC (HLX15-SC-NDMM-001) trial, a biosimilar version of Darzalex Faspro, as a 1L treatment for newly diagnosed multiple myeloma (NDMM)  The study will compare HLX15-SC vs. US-licensed Darzalex Faspro in transplant-ineligible NDMM patients, evaluating PK similarity, safety, tolerability, immunogenicity, and efficacy in combination with lenalidomide & dexamethasone (Rd)  HLX15 is an anti-CD38 daratumumab biosimilar candidate for both IV and SC formulations. In Feb 2025, Henlius licensed exclusive commercialization rights for both formulations to Dr. Reddy’s across the U.S. and 42 European countries & regions  Formycon Partners with OneSource Specialty Pharma for Biosimilars                 Company: Formycon and OneSource Specialty Pharma                  Product: N/A                 Active Ingredient: N/A                 Reference Product: N/A                 Reference Product Company: N/A                 Disease: N/A                 Date: Jul 14, 2026                 Shots:  Formycon and OneSource Specialty Pharma have entered into a strategic manufacturing partnership for biosimilars  As per the deal, OneSource will act as Formycon’s strategic manufacturing partner, providing integrated Drug Substance (DS) and Drug Product (DP) manufacturing from its advanced biologics facility in Bangalore, India  The collaboration combines Formycon’s biosimilar development expertise with OneSource’s end-to-end biologics manufacturing capabilities to advance Formycon’s global biosimilar programs  Organon and Samsung Bioepis Expand Commercialisation Agreement to Broaden Biosimilar Access in Australia                 Company: Organon and Samsung Bioepis                   Product: N/A                 Active Ingredient: N/A                 Reference Product: N/A                 Reference Product Company: N/A                 Disease: N/A                 Date: Jul 16, 2026                 Shots:  Organon & Samsung Bioepis have expanded their development and commercialisation agreement to commercialise a new biosimilar in Australia  As per the deal, Organon will receive exclusive commercial rights to the biosimilar in Australia while Samsung Bioepis will be responsible for full development, manufacturing & regulatory responsibilities  The amended agreement expands their collaboration to 4 biosimilars in Australia, broadening access to biosimilar medicines across multiple therapeutic areas  Henlius Reports First Patient Dosing in P-I Trial of HLX18 (Biosimilar, Opdivo) in China                 Company: Henlius                 Product: HLX18                 Active Ingredient: Nivolumab                 Reference Product: Opdivo                 Reference Product Company: BMS                 Disease: All Approved Indications                 Date: Jul 16, 2026                 Shots:  Henlius has dosed the first patient in China in the P-I (HLX18-MRST001) trial assessing its nivolumab biosimilar, HLX18, in patients with resected solid tumors  The study will compare HLX18 vs. Opdivo in patients with resected solid tumors, evaluating PK similarity, efficacy, safety, and immunogenicity following monotherapy  HLX18 is Henlius’ nivolumab biosimilar candidate, developed under global biosimilar guidelines. Reference nivolumab is approved worldwide for multiple cancers, including melanoma, NSCLC, RCC, HCC, urothelial, gastric, esophageal, colorectal, and head & neck cancers  Samsung Bioepis and Harrow Present Interim P-IV PMS Study Data on SB11 (Biosimilar, Lucentis) at ASRS 2026                 Company: Samsung Bioepis & Harrow                 Product: SB11                 Active Ingredient: Ranibizumab                 Reference Product: Lucentis                 Reference Product Company: Genentech                 Disease: All Approved Indications                 Date: Jul 20, 2026                 Shots:  Samsung Bioepis & Harrow have reported interim data from a P-IV post-marketing surveillance study on SB11, a biosimilar version of Lucentis (ranibizumab), conducted in South Korea from May 2022 to May 2026  The interim analysis incl. 298 of 305 enrolled pts (182 treatment-naïve & 116 switched), with investigator-determined dosing intervals & follow-up through 24wks. after the first dose  Treatment-naïve pts showed greater improvements in BCVA & CST than switched pts, with mean BCVA changes of -0.10 vs -0.03 & CST changes of -95 vs -53µm. Outcomes did not differ significantly by indication, while shorter disease duration was associated with better visual outcomes  Accord BioPharma Reports Commercial Availability of Osvyrti and Jubereq (Biosimilar, Prolia & Xgeva) in the US                 Company: Accord BioPharma                   Product: Osvyrti & Jubereq                 Active Ingredient: Denosumab                 Reference Product: Prolia & Xgeva                 Reference Product Company: Amgen                 Disease: All Approved Indications                 Date: Jul 23, 2026                 Shots:  Accord BioPharma has reported the launch of Osvyrti & Jubereq, interchangeable biosimilars to Amgen’s Prolia & Xgeva (denosumab), in the US  Osvyrti (60mg PFS) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer & women on adjuvant aromatase inhibitors for breast cancer  Jubereq (120mg/1.7mL vial) prevents SREs in adults with bone-involved malignancies & multiple myeloma, treats giant cell tumors of bone in adults & skeletally mature adolescents with unresectable or high-morbidity tumors, & manages hypercalcemia of malignancy refractory to bisphosphonate therapy  Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation                 Company: Biocon                 Product: Yesintek                 Active Ingredient: Ustekinumab                 Reference Product: Stelara                 Reference Product Company: J&J                 Disease: All Approved Indications                 Date: Jul 29, 2026                 Shots:  Health Canada has approved Yesintek Autoinjector (45 mg/0.05 mL & 90 mg/mL), a biosimilar version of Stelara (ustekinumab)  Yesintek is indicated for the treatment of mod. to sev. plaque psoriasis in pts (≥6yrs.), active psoriatic arthritis in adults, mod. to sev. active Crohn’s disease & ulcerative colitis in adults  Yesintek was previously approved as SC injection in prefilled syringe (45 mg/0.5ml & 90mg/ml) & vial (45 mg/0.5ml) format as well as IV infusion 130mg/26mL (5mg/mL) in Oct 2025  Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog)                 Company: Meitheal                   Product: Garzulys                 Active Ingredient: Insulin Aspart                 Reference Product: NovoLog                 Reference Product Company: Novo Nordisk                 Disease: All Approved Indications                 Date: Jul 30, 2026                 Shots:  The US FDA has approved Garzulys (SC & IV), a biosimilar to NovoLog (insulin aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus   Garzulys was developed through a collaboration among Tonghua Dongbao, NKF, Xentria, Meitheal, & Emerge. Tonghua Dongbao developed the drug substance, NKF the drug product, Xentria led clinical development, Meitheal managed US regulatory activities, & Emerge is the BLA holder  The 2023 Tonghua Dongbao–NKF collaboration incl. Garzulys & 2 insulin biosimilar candidates in development. Through its license with Emerge, Meitheal holds exclusive US commercialization rights for Garzulys & both pipeline candidates  Fresenius Kabi Reports FDA and EMA Acceptance of PB016 (Biosimilar, Entyvio) for Review                 Company: Fresenius Kabi                   Product: PB016                 Active Ingredient: Vedolizumab                 Reference Product: Entyvio                 Reference Product Company: Takeda                 Disease: All Approved Indications                 Date: Jul 31, 2026                 Shots:  The US FDA and EMA have accepted BLA & MAA, respectively for PB016, a biosimilar version of Entyvio (vedolizumab) lyophilized vial for IV administration  BLA was supported by an extensive development program assessing PB016 vs Entyvio, to evaluate its similarity to the reference product, consistent with regulatory requirements for biosimilar approval  PB016 is an integrin receptor antagonist for mod. to sev. active ulcerative colitis & Crohn’s disease, developed by Polpharma, with Fresenius Kabi holding exclusive global commercialization rights outside the Middle East & North Africa, pending approvals  The post Key Biosimilars Events of July 2026  appeared first on PharmaShots.