Shots:
- May 2026 saw strong biosimilar momentum with key approvals including Bevqolva (Health Canada), Langlara and Immgolis/Immgolis Intri (US FDA), Bysumlog and Dazparda (EC), and Eyzanfy (MFDS), expanding competition across oncology, diabetes, immunology, and ophthalmology.
- Strategic progress continued with Henlius’ FDA IND clearance for HLX05-N, alongside partnerships between IQVIA–Kexing Biopharm and Polpharma–Tuteur, supporting global development and commercialization efforts.
- Commercialization accelerated through the EU launches of FYB203 and Opuviz, as well as Samsung Bioepis’ ustekinumab biosimilar launch in Japan, highlighting growing global biosimilar adoption and market expansion.
Company: CuraTeQ Biologics
Product: Bevqolva
Active Ingredient: Bevacizumab
Reference Product: Avastin
Reference Product Company: Genentech
Disease: All Approved Indications
Date: May 01, 2026
Shots:
- Health Canada has granted NOC to Bevqolva (bevacizumab), a biosimilar version of Genentech’s Avastin
- Bevacizumab, a humanized mAb, inhibits angiogenesis by blocking VEGF-A to slow tumor vascular growth in cancers like colorectal and lung. Marketed by Roche/Genentech as Avastin, it is available in 100 mg and 400 mg formulations
- In 2025, Bevqolva received MHRA approval and was launched in the UK. It is under CHMP review with the EMA, while CuraTeQ Biologics also has two biosimilar applications under review by Health Canada
Company: Lannett Company and Sunshine Lake Pharma
Product: Langlara
Active Ingredient: Insulin Glargine
Reference Product: Lantus
Reference Product Company: Sanofi
Disease: Diabetes Mellitus
Date: May 04, 2026
Shots:
- The US FDA has approved Langlara, an interchangeable biosimilar to Lantus (insulin glargine), for the treatment of adults & pediatric patients with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus
- Approval was based on the extensive data, incl. analytical, preclinical & clinical program, showing non-inferiority of Langlara to Lantus in terms of PK/PD, efficacy, safety profile & immunogenicity in pts with type 1 & type 2 diabetes
- Langlara is manufactured by Sunshine Lake Pharma, the pharmaceutical arm of HEC Group, & is exclusively commercialized in the US through Lanexa Biologics, a newly formed wholly owned subsidiary of Lannett Company
Company: Henlius
Product: HLX05-N
Active Ingredient: Cetuximab
Reference Product: Erbitux
Reference Product Company: Eli Lilly
Disease: Metastatic Colorectal Cancer
Date: May 10, 2026
Shots:
- The US FDA has granted IND clearance to HLX05-N, a biosimilar version of Erbitux (cetuximab) for the treatment of metastatic colorectal cancer (mCRC)
- HLX05-N is developed by Henlius in accordance with biosimilar guidelines in China, the EU, & the US, and showed high similarity to reference cetuximab in analytical & non-clinical comparative studies
- Cetuximab is an anti-EGFR monoclonal antibody that binds to EGFR, blocking ligand binding & signaling to inhibit proliferation, induce apoptosis, & suppress angiogenesis, while also mediating ADCC to enable immune cells to kill tumor cells
Company: IQVIA and Kexing Biopharm
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: May 13, 2026
Shots:
- IQVIA is expanding its collaboration with Kexing Biopharm to advance a global multi-product biosimilar development and commercialization program
- As part of the collaboration, IQVIA will provide end-to-end development, regulatory, analytics, and commercialization support to accelerate Kexing’s global biosimilar expansion while maintaining high quality and scientific standards
- The collaboration also integrates IQVIA’s AI-enabled clinical trial capabilities to streamline protocol design, site selection, and study execution, accelerating development and improving trial efficiency
Company: Alteogen
Product: Eyzanfy
Active Ingredient: Aflibercept
Reference Product: Eylea
Reference Product Company: Bayer
Disease: Neovascular (wet) age-related macular degeneration, Diabetic macular edema, Choroidal neovascularization, Proliferative diabetic retinopathy (PDR), and Macular edema following retinal vein occlusion
Date: May 15, 2026
Shots:
- The Korean MFDS has approved Eyzanfy (ALT-L9), a biosimilar version of Eylea (aflibercept)
- In 2025, ALT-L9 received EC approval as a brand name of Eyluxvi
- Approval was based on P-III trial across 12 countries in 431 wAMD pts, demonstrating Eyluxvi’s efficacy, safety, and therapeutic equivalence comparable to Eylea
Company: Sandoz
Product: Bysumlog & Dazparda
Active Ingredient: Insulin Lispro & Insulin Aspart
Reference Product: Humalog & NovoRapid
Reference Product Company: Eli Lilly & Novo Nordisk
Disease: Improve Glycemic Control in Adults, and Pediatric Patients with Diabetes Mellitus
Date: May 15, 2026
Shots:
- The EC has approved Bysumlog & Dazparda, the biosimilar versions of Humalog (insulin lispro) & NovoRapid (insulin aspart), respectively, as prefilled pens
- Bysumlog is approved for the treatment and initial stabilisation of diabetes mellitus in adults & children, while Dazparda is approved for diabetes treatment in pts (≥1yr.). Both demonstrated equivalent efficacy & comparable safety to their reference medicines
- In 2018, Sandoz entered an agreement with Gan & Lee to commercialize biosimilar insulin aspart, lispro, & glargine products, with Sandoz holding commercialization rights across EU & other key global markets, while Gan & Lee managing development, manufacturing, & supply
Company: Accord Biopharma
Product: Immgolis & Immgolis Intri
Active Ingredient: Golimumab
Reference Product: Simponi & Simponi Aria
Reference Product Company: Johnson & Johnson
Disease: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Ulcerative Colitis
Date: May 18, 2026
Shots:
- The US FDA has approved Immgolis & Immgolis Intri, the interchangeable biosimilar versions of Simponi & Simponi Aria (golimumab), respectively
- Immgolis & Immgolis Intri are both approved for the treatment of adults with mod. to sev. active rheumatoid arthritis in combination with methotrexate, while Immgolis is additionally approved for mod. to sev. active ulcerative colitis in adults
- Both biosimilars were developed by Bio-Thera, which will continue managing manufacturing & supply, while Accord BioPharma holds exclusive US commercialization rights, with launches planned for Q4’26
Company: Formycon and Klinge Biopharma
Product: FYB203
Active Ingredient: Aflibercept
Reference Product: Eylea
Reference Product Company: Bayer
Disease: Neovascular (wet) age-related macular degeneration, Diabetic macular edema, Choroidal neovascularization, Proliferative diabetic retinopathy (PDR), and Macular edema following retinal vein occlusion
Date: May 19, 2026
Shots:
- Formycon and licensing partner Klinge Biopharma have reported the EU launch of FYB203, a biosimilar version of Eylea 2mg (aflibercept)
- FYB203 is now available in the EU as a PFS under the brand names Ahzantive and Baiama. The launch began on May 15, 2026, in key markets including Germany, France, and Italy, with further expansion across Central and Eastern Europe planned in the coming months
- In March 2026, Formycon signed a settlement and licensing agreement with Regeneron and Bayer, enabling the European launch on May 15, 2026. Earlier, in October 2025, Formycon secured a U.S. launch timeline for Q4’26, with the possibility of an earlier entry under certain conditions
Company: Samsung Bioepis and NIPRO
Product: Ustekinumab BS
Active Ingredient: Ustekinumab
Reference Product: Stelara
Reference Product Company: Johnson & Johnson
Disease: Plaque Psoriasis and Psoriatic Arthritis
Date: May 19, 2026
Shots:
- Samsung Bioepis has reported the launch of Ustekinumab BS 45 mg Syringe for SC Injection 「NIPRO」, a biosimilar version of Stelara, in Japan, marking the company’s first commercialized product in the country
- The biosimilar will be commercialized by NIPRO CORPORATION under a strategic partnership between Samsung Bioepis & NIPRO in 2025, focussed on developing & commercializing multiple biosimilars in Japan, incl. ustekinumab
- Japan’s PMDA granted marketing authorization for the therapy in Dec 2025 for plaque psoriasis and psoriatic arthritis, with the biosimilar added to Japan’s NHI Drug Price Standard following an Official Gazette announcement on May 19, 2026
Company: Polpharma Partners and Tuteur
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: May 22, 2026
Shots:
- Polpharma Biologics has entered into a licensing agreement with Tuteur to commercialize a biosimilar candidate for autoimmune diseases across Latin America, excl. Brazil
- As per the deal, Tuteur will handle commercialization, marketing, & distribution in the licensed territories, while Polpharma will be responsible for the development & manufacturing of the biosimilar candidate
- The biosimilar candidate is being developed as a potentially effective and well-tolerated treatment for autoimmune conditions, with regulatory submission expected within the next 3yrs.
Company: Samsung Bioepis
Product: Opuviz
Active Ingredient: Aflibercept
Reference Product: Eylea
Reference Product Company: Bayer
Disease: Neovascular (wet) age-related macular degeneration, Diabetic macular edema, Choroidal neovascularization, Proliferative diabetic retinopathy (PDR), and Macular edema following retinal vein occlusion
Date: May 29, 2026
Shots:
- Samsung Bioepis to directly commercialize Opuviz 40 mg/mL solution for injection in a vial, a biosimilar version of Eylea (aflibercept), across EU
- Opuviz is indicated to treat wet age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), diabetic macular oedema (DME), and myopic choroidal neovascularization (myopic CNV)
- Additionally, Opuviz 40 mg/mL pre-filled syringe received a positive CHMP opinion in Nov 2025 and is expected to launch in the market in Q3’26
Note: The following drug has been granted CHMP; however, no PR was available:
- Vislyfa (Biosimilar, Lucentis)
Related Post: Key Biosimilars Events of April 2026
