Key Biosimilars Events of August 2026 

Shots:  In August, biosimilar approvals and launches gained strong momentum with Biocon’s Yesafili (Eylea) and Yesintek (Stelara), FDA approval of rituximab from Dr. Reddy’s and Fresenius Kabi, and Celltrion’s European launch of Omlyclo (Xolair).   Global licensing and commercialization partnerships continued to drive biosimilar expansion with collaborations spanning North America, Europe, ASEAN, and MENA markets.   The biosimilar pipeline continued to broaden across key therapeutic areas with emerging programs targeting Taltz, Kadcyla, and Entyvio, alongside developments in immunology, oncology, ophthalmology, and inflammatory diseases.  Biocon Launches Yesafili (Biosimilar, Eylea) in the US                 Company: Biocon                 Product: Yesafili                 Active Ingredient: Aflibercept                 Reference Product: Eylea                 Reference Product Company: Bayer                 Disease: All Approved Indications                 Date: Aug 03, 2026                 Shots:  Biocon has reported the commercial launch of Yesafili, a biosimilar version of Eylea 2mg (aflibercept), in the US, which was previously approved & granted interchangeable designation  In the P-III (INSIGHT) study in Diabetic Macular Edema (DME), Yesafili showed no clinically meaningful differences from Eylea in PK, safety, efficacy, or immunogenicity  Yesafili is a VEGF inhibitor approved for the treatment of Neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, DME, & diabetic retinopathy  Fresenius Kabi & Dr Reddy’s Laboratories Reports the US FDA Approval of Rituximab (Biosimilar, Rituxan)                 Company: Fresenius Kabi & Dr Reddy’s Laboratories                 Product: Rituximab                 Active Ingredient: Rituximab                 Reference Product: Rituxan                  Reference Product Company: Genentech & Biogen                 Disease: All Approved Indications                 Date: Aug 03, 2026                 Shots:  The US FDA has approved Rituximab, a biosimilar version of Rituxan developed by Dr. Reddy’s Laboratories, supported by analytical, non-clinical, and clinical data demonstrating high similarity and no clinically meaningful differences from Rituxan, meeting US biosimilar requirements   Rituximab is a mAb targeting CD20 on B cells, leading to B-cell depletion through immune-mediated mechanisms. It is approved in the US for several hematologic malignancies and autoimmune diseases, including non-Hodgkin lymphoma, CLL, RA, GPA, and MPA   Under an exclusive commercialization agreement, Fresenius Kabi will commercialize the biosimilar in the U.S., while Dr. Reddy’s Laboratories developed, manufactured, and submitted it for approval  Samsung Bioepis Launches Opuviz 40 mg/mL PFS (Biosimilar, Eylea) in the EU                  Company: Samsung Bioepis                 Product: Opuviz                 Active Ingredient: Aflibercept                 Reference Product: Eylea                 Reference Product Company: Bayer                 Disease: All Approved Indications                 Date: Aug 10, 2026                 Shots:  Samsung Bioepis has reported the commercial launch of Opuviz 40 mg/mL solution (PFS), a biosimilar version of Eylea (aflibercept) across the EU  OPUVIZ (aflibercept) is a VEGF inhibitor that blocks abnormal blood vessel growth and leakage in the eye. Samsung Bioepis launched the 40 mg/mL vial in May’26. The PFS formulation received a positive CHMP opinion in Nov’25 for the same indications  OPUVIZ 40 mg/mL vial was approved by the EC in Nov’24 and MHRA in Apr’25 for adults with wet AMD, RVO-related macular oedema, DME, and myopic CNV  Mabwell Reports ASEAN Partnerships for Its Aflibercept Biosimilar (Biosimilar, Eylea)                  Company: Mabwell                 Product: Aflibercept                 Active Ingredient: Aflibercept                 Reference Product: Eylea                 Reference Product Company: Bayer                 Disease: All Approved Indications                 Date: Aug 11, 2026                 Shots:  Mabwell has signed licensing and commercialization agreements with local partners in the Philippines, Vietnam, and Malaysia for its aflibercept biosimilar, a biosimilar version of Eylea  As per the deal, Mabwell and its partners jointly advance the product’s registration and commercialization in these markets  Aflibercept is a VEGF inhibitor approved for the treatment of Neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, DME, & diabetic retinopathy  Henlius and Sandoz Partner on Up to 10 Biosimilar mAbs and ADC Products                  Company: Henlius and Sandoz                 Product: HLX05-N, HLX16, and Belimumab                 Active Ingredient: Cetuximab, Evolocumab, and Belimumab                 Reference Product: Erbitux, Repatha, and Benlysta                 Reference Product Company: Eli Lilly, Amgen, and GSK                 Disease: All Approved Indications                 Date: Aug 17, 2026                 Shots:  The deal incl. ~10 biosimilars or related components, incl. 3 initial assets: HLX05-N (cetuximab), HLX16 (evolocumab), & a proposed belimumab biosimilar, plus an option for HLXTE-HAase1001, a recombinant human hyaluronidase  Sandoz will receive exclusive rights to register & commercialize the assets globally outside China, with both parties sharing development & lifecycle activities. Territories vary by asset, with HLX16 & belimumab biosimilar covered exclusively worldwide (ex-China)  Henlius will receive ~$322M in upfront, milestone & non-refundable option fee, incl. ~$100.5M expected to be invoiced in 2026. For HLX05-N, exclusive territories include the US, Canada, EU, UK, Switzerland, Japan, Australia & New Zealand, alongside semi-exclusive rights in select Asian & other markets  Biocon Secures FDA Approval for Yesintek (Biosimilar, Stelara)                 Company: Biocon                 Product: Yesintek                   Active Ingredient: Ustekinumab                 Reference Product: Stelara                 Reference Product Company: J&J                 Disease: All Approved Indications                 Date: Aug 18, 2026                 Shots:  The US FDA has approved Yesintek 45 mg/0.5 mL and 90 mg/mL single-dose prefilled autoinjectors, a biosimilar version of Stelara (ustekinumab)  Yesintek is indicated for mod. to sev. plaque psoriasis and active psoriatic arthritis in patients aged 6 years and older, and for mod. to sev. active Crohn’s disease and ulcerative colitis in adults  Yesintek was initially approved in November 2024  Bio-Thera Partners with Avalon Pharma to Commercialize BAT2406 (Biosimilar, Dupixent) in Saudi Arabia and MENA                  Company: Bio-Thera Partners with Avalon Pharma                 Product: BAT2406                 Active Ingredient: Dupilumab                 Reference Product: Dupixent                 Reference Product Company: Sanofi & Regeneron                 Disease: All Approved Indications                  Date: Aug 18, 2026                 Shots:  Avalon Pharma and Bio-Thera Solutions have signed commercialization and licensing agreements for BAT2406 (dupilumab), a proposed biosimilar of Dupixent, covering Saudi Arabia and the broader MENA region  As per the deal, Bio-Thera will handle BAT2406’s development, manufacturing, and supply, while Avalon Pharma will manage regulatory approvals and commercialization across the licensed territory  BAT2406 is a fully human mAb IgG4 that inhibits IL-4 and IL-13 signaling by binding to the shared IL-4 receptor alpha (IL-4Rα) subunit  Alvotech and Lotus Partner to Commercialize AVT34 (Biosimilar, Imfinzi) and AVT87 (Biosimilar, Hemlibra) Across US and 8 Asian Countries                  Company: Alvotech and Lotus                 Product: AVT34 & AVT87                 Active Ingredient: Durvalumab & Emicizumab                 Reference Product: Imfinzi & Hemlibra                 Reference Product Company: Astrazeneca & Genentech                 Disease: All Approved Indications                  Date: Aug 21, 2026                 Shots:  Alvotech has entered a strategic licensing & commercialization agreement with Lotus Pharmaceutical for AVT34, a proposed Imfinzi (durvalumab) biosimilar, & AVT87, a proposed Hemlibra (emicizumab) biosimilar, in the US & selected Asian markets  Under the US semi-exclusive deal, Alvotech & Lotus will jointly commercialize AVT34 and AVT87, with Lotus commercializing the products through Alvogen; Alvotech will lead development, US marketing authorizations & serve as the exclusive supplier across all markets  Lotus will hold exclusive commercialization rights for AVT34 & AVT87 in eight Asian markets, handling local regulatory submissions & commercialization, while Alvotech could receive ~$150M in upfront & milestone payments plus ongoing commercial product supply revenues  Celltrion Reports Launch of Omlyclo 300mg (Biosimilar, Xolair) in Europe                  Company: Celltrion                 Product: Omlyclo 300mg                 Active Ingredient: Omalizumab                 Reference Product: Xolair                 Reference Product Company: Novartis and Genentech                 Disease: All Approved Indications                  Date: Aug 24, 2026                 Shots:  Celltrion has reported the launch of Omlyclo (300mg in PFS & autoinjector), a biosimilar version of Xolair (omalizumab), for the treatment of pts with allergic asthma & chronic spontaneous urticaria (CSU) in Europe  Following the EU launch of Omlyclo 75mg & 150mg last year, Celltrion began rolling out the 300mg dose in Germany, the UK & France mid-year, with supply expanding to other markets & full European rollout planned by year-end  Omalizumab is a humanized mAb that binds free IgE to reduce the release of inflammatory mediators across the allergic cascade in allergic asthma, CSU, & CRSwNP  Samsung Bioepis Begins P-I Trial of SB35 (Biosimilar, Taltz)                   Company: Samsung Bioepis                 Product: SB35                 Active Ingredient: Ixekizumab                 Reference Product: Taltz                 Reference Product Company: Eli Lilly                 Disease: All Approved Indications                  Date: Aug 28, 2026                 Shots:  Samsung Bioepis Initiates Phase 1 Trial of SB35 (ixekizumab), a Biosimilar version of Taltz   The P-I randomized, double-blind study will compare single-dose SB35 and Taltz in healthy participants for PK, safety, tolerability, and immunogenicity. Participants will be randomized 1:1, with 1EP including AUCinf, Cmax, and AUClast through Day 85  Ixekizumab is a humanized IgG4 mAb that selectively binds to IL-17A, blocking IL-17 receptor signaling and reducing chronic inflammation associated with plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and enthesitis-related arthritis.  Formosa Pharmaceuticals Submits a CTA for TSY-110 (Biosimilar, Kadcyla)                 Company: Formosa Pharmaceuticals                 Product: TSY-110                 Active Ingredient: Ado-trastuzumab Emtansine                 Reference Product: Kadcyla                 Reference Product Company: Roche                 Disease: All Approved Indications                  Date: Aug 28, 2026                 Shots:  Formosa has submitted a CTA to European regulatory authorities for a pivotal trial of TSY-110 (ado-trastuzumab emtansine), a biosimilar Version of Roche’s Kadcyla for HER2-positive breast cancer  The trial will evaluate TSY-110’s safety, tolerability, PK, and immunogenicity versus the reference product; preclinical data show high biosimilarity, consistent DAR, and comparable plasma kinetics  TSY-110 (EG12043) is an ADC biosimilar co-developed by Formosa Pharmaceuticals and EirGenix, combining trastuzumab with mertansine to selectively target HER2-overexpressing cancer cells. The program aims to expand access to cost-effective biosimilar ADC treatments in global regulated markets  Alvotech Reports US FDA BLA Acceptance for AVT80 (Biosimilar, Entyvio)                 Company: Alvotech                 Product: AVT80                 Active Ingredient: vedolizumab                 Reference Product: Entyvio                 Reference Product Company: Takeda                 Disease: All Approved Indications                  Date: Aug 31, 2026  Shots:  The US FDA has accepted a BLA for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) PFS & autoinjector for SC administration  BLA was backed by analytical, PK & immunogenicity data showing biosimilarity with the reference product. Plus, under a partnership with Teva, Alvotech is responsible for development & manufacturing of AVT80, while Teva will handle its commercialization  In Feb 2026, Alvotech reported positive pivotal PK study results for AVT80, which met all 1EP vs Entyvio in healthy adults, with regulators considering the study pivotal for demonstrating clinical similarity of AVT16 (Biosimilar, Entyvio IV) & AVT80  The post Key Biosimilars Events of August 2026  appeared first on PharmaShots.