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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
