Skip to content Skip to footer

Mabwell Reports ASEAN Partnerships for Its Aflibercept Biosimilar (Biosimilar, Eylea) 

 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…

Read more

Samsung Bioepis

Samsung Bioepis Launches Opuviz 40 mg/mL PFS (Biosimilar, Eylea) in the EU 

 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…

Read more

Samsung Bioepis Partners with Teva  to Commercialize Opuviz  (Biosimilar, Eylea) in Canada 

 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…

Read more

Key Biosimilars Events of June 2026 

Shots:  June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC),  and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology,  ophthalmology,  oncology, osteoporosis, and reproductive medicine.  Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.  Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.  Celltrion Seeks…

Read more

Celltrion

Celltrion Receives ANVISA Approval for Eydenzelt (Biosimilar, Eylea) 

Shots:  The ANVISA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept)  Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor  Eydenzelt is indicated for adults with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (CRVO/BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (CNV)  Ref: Gov.br |   Image: Celltrion   | Press Release Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea  …

Read more

Formycon and Klinge Biopharma Launch FYB203 (Biosimilar, Eylea) in the EU 

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…

Read more

Alteogen Reports the MFDS Approval of Eyzanfy (Biosimilar, Eylea) 

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  Ref: Alteogen | Image: Alteogen | Press Release Related News:- Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s…

Read more

Formycon Inks Settlement and Licensing Deal with Regeneron & Bayer for Commercialization of FYB203 (Biosimilar, Eylea)  

Shots:  Formycon has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of FYB203, a biosimilar version of Eylea 2 mg (aflibercept 0.05 ml of 40 mg/mL solution), in the EU  Under the agreement, both products may launch in the EU and other regions, including LATAM and Asia-Pacific, from May 2026. Earlier, in October 2025, Formycon secured…

Read more