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.
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
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
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
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
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
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
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
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
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
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.
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
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
