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Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)

Shots: The US FDA has received resubmitted BLA of AVT05, a biosimilar version of Simponi & Simponi Aria, and AVT06, a biosimilar to Eylea 2mg (aflibercept)  Resubmissions follow Alvotech’s response to the FDA’s PAAL regarding its Reykjavik facility, alongside responses to observations from a May 2026 routine cGMP inspection & ongoing enhancements to quality systems…

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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…

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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…

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Top 20 Biopharma Companies of 2026    

Shots: The biopharma industry is a multi-hundred-billion-dollar market, with a projected compound annual growth rate (CAGR) of 8.6%, the global biopharma market is expected to reach $1.41T by 2034. Eli Lilly and Co. ranked first with $65.17B, followed by Pfizer ($61.19B) and AbbVie ($61.16B), reflecting strong market concentration among large-cap innovators with diversified, high-value portfolios …

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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…

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Zydus Lifesciences  Launches Anyra (Biosimilar, Eylea) in the Canada 

Shots:  Zydus Lifesciences has launched Anyra (aflibercept 2 mg), a biosimilar version of Eylea. Zydus has inked an agreement with Regeneron and Bayer  Aflibercept is a Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF), which are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability…

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Sandoz

Sandoz Reports the US FDA’s Approval of Enzeevu (Biosimilar, Eylea) 

Shots:  The US FDA has approved Enzeevu, a biosimilar version of Eylea (aflibercept), for multiple retinal indications, with an anticipated launch in Q4’26   Aflibercept is a recombinant fusion protein that blocks VEGF-A and PlGF, inhibiting abnormal blood vessel growth   Enzeevu (aflibercept-abzv) is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO),…

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Sandoz

Sandoz Lauches Enzeevu (Biosimilar, Eylea) in the Canada 

Shots:  Sandoz has reported Enzeevu (Aflibercept), a biosimilar version of Eylea, is now available in Canada   Enzeevu is a single-use, PFS intravitreal injection delivering 2 mg aflibercept (2 mg/0.05 mL). It closely resembles the reference product   Enzeevu is approved for all its indications, including neovascular (wet) age-related macular degeneration (AMD), macular edema due to CRVO or BRVO, diabetic macular edema (DME), and myopic…

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