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Merck Reports the P-IIb/III (BRUNELLO) Trial Data on Remigromig for Diabetic Macular Edema

Shots: Merck has reported the P-IIb/III (BRUNELLO) trial data assessing remigromig (MK-3000, formerly EYE103;0.5 & 0.8mg, IVT, Q4W) vs 0.5mg ranibizumab (Q4W) in 984 adults with diabetic macular edema (DME)  At 52 wks., both remigromig doses demonstrated non-inferiority to 0.5mg ranibizumab in mean change from baseline in best-corrected visual acuity in pts with DME, with…
September 25, 2026

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NEWS

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…
August 11, 2026

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Samsung Bioepis
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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…
August 10, 2026

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NEWS

Biocon Launches Yesafili (Biosimilar, Eylea) in the US

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…
August 4, 2026

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Samsung Bioepis
NEWS

Samsung Bioepis Began Direct Commercialization of Byooviz (Biosimilar, Lucentis) Across Europe

Shots: Samsung Bioepis has reported the direct commercialization of Byooviz, a biosimilar version of Lucentis (ranibizumab) across Europe, with market availability expected in Q2’26 Byooviz (0.5 mg/0.05 ml) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due…
January 2, 2026

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NEWS

Formycon Receives the US FDA Approval for Nufymco (Biosimilars, Lucentis)

Shots:  The US FDA has approved Nufymco (ranibizumab-leyk), an interchangeable biosimilar of Lucentis, with Zydus serving as its commercialization partner in the US  Nufymco is an interchangeable Lucentis biosimilar developed by Formycon, approved for the treatment of wet AMD, diabetic macular edema, diabetic retinopathy, retinal vein occlusion-related macular edema, and myopic choroidal neovascularization  Zydus secured exclusive US and Canada rights to Formycon’s Keytruda…
December 23, 2025

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Samsung Bioepis
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Samsung Bioepis Receive the CHMP Positive Opinion for Byooviz (Biosimilar, Lucentis) 

Shots:  The CHMP has recommended Samsung Bioepis’ Byooviz  (0.5 mg/0.05 ml PFS), a biosimilar version of Lucentis (ranibizumab). The PFS presentation is expected to launch in Q2’26  Byooviz is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and…
December 2, 2025

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Celltrion
NEWS

Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives Health Canada Approval to Treat Multiple Retinal Diseases

Shots: Health Canada has approved Eydenzelt, a biosimilar version of Eylea (aflibercept 2mg), in both vial & PFS presentation for all the indications of the reference product Approval was based on extensive analytical, nonclinical, & clinical data, incl. a global 52wk. P-III trial of Eydenzelt vs Eylea in 348 pts with diabetic macular edema, which met…
November 28, 2025

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NEWS

4D Molecular Therapeutics Collaborates with Otsuka Pharmaceutical to Develop and Commercialize 4D-150 in the APAC Region

Shots: 4DMT has granted Otsuka exclusive rights to develop & commercialize 4D-150 for retinal vascular diseases, incl. wet age-related macular degeneration (wet AMD) & diabetic macular edema (DME) in Japan, China, Australia & other APAC markets, while retaining rights in other regions As per the deal, Otsuka will lead all regulatory & commercialization efforts in…
October 31, 2025

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