Aflibercept intravitreal manufacturers

About aflibercept intravitreal

Aflibercept intravitreal manufacturers include the originators Regeneron (Eylea in the US) and Bayer (Eylea outside the US), and biosimilar makers Biocon, Samsung Bioepis, Sandoz, Formycon, Celltrion, Amgen and Alteogen. Aflibercept is a recombinant fusion protein that acts as a decoy receptor for VEGF. It is injected into the eye to treat neovascular age-related macular degeneration (nAMD), diabetic macular oedema, retinal vein occlusion and myopic choroidal neovascularisation. Pharmaceutical companies can source aflibercept 2 mg biosimilar dossiers through out-licensing, supply or technology transfer. Dossiers are available in EU biosimilar and US 351(k) formats.

Aflibercept intravitreal key facts

Aflibercept intravitreal manufacturers and licensing history

Regeneron developed aflibercept and markets Eylea in the US. Bayer holds the rights outside the US. The FDA approved Eylea for nAMD in 2011, followed by diabetic macular oedema, retinal vein occlusion and diabetic retinopathy. A higher-dose 8 mg formulation, Eylea HD, was approved in the US in 2023.

The biosimilar landscape is now crowded. In the EU, at least seven aflibercept biosimilars have been approved since Biocon's Yesafili in September 2023. In the US, the FDA approved the first biosimilars in May 2024, and Amgen launched Pavblu in October 2024 after a court refused Regeneron an injunction.

Most other launches are governed by patent settlements. Samsung Bioepis's settlement allows Opuviz to launch in the UK from January 2026, in the rest of Europe from April 2026 and in the US in January 2027. Biocon's settlement allows a US launch of Yesafili in the second half of 2026.

Aflibercept is produced in mammalian cell culture. Buyers should confirm the biosimilar's comparability data, the GMP status of the drug substance and drug product sites, and the device (vial or prefilled syringe) before choosing a licensing partner.

Aflibercept intravitreal dosage forms and dossier types

Aflibercept intravitreal is approved as a 40 mg/ml solution for a 2 mg dose, and as a high-dose 8 mg formulation. Biosimilar aflibercept manufacturers develop the 2 mg product, because Eylea 2 mg is the reference product.

Aflibercept intravitreal regulatory and patent status

The FDA approved Eylea in November 2011. The EU approved it in 2012. Biosimilar approvals began in the EU in September 2023 and in the US in May 2024.

Regeneron and Bayer have litigated patents against several biosimilar makers. Launch timing now depends mostly on settlements: Amgen's Pavblu launched in the US in October 2024, Biocon's Yesafili may launch in the US in the second half of 2026, and Samsung Bioepis's Opuviz in January 2027. In Europe, settlements allow staged launches from 2026. Check current settlement terms and national patent registers before planning a launch.

Aflibercept intravitreal mechanism of action and therapeutic use

Aflibercept binds VEGF-A, VEGF-B and placental growth factor, which stops them activating their receptors. This reduces abnormal blood vessel growth and leakage in the retina. Aflibercept is injected into the eye for nAMD, diabetic macular oedema, macular oedema after retinal vein occlusion and myopic choroidal neovascularisation. After loading doses, it can be given every 8 weeks or at longer intervals.

Aflibercept intravitreal licensing and sourcing

Aflibercept suppliers and licensing partners typically offer biosimilar dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, US FDA), comparability data, device format, patent and settlement position, and territory availability. Current offers and supplier contacts are listed among the aflibercept manufacturers on Pipelinepharma.

Frequently asked questions about aflibercept intravitreal

Who are the main aflibercept intravitreal manufacturers? Regeneron and Bayer make the originator, Eylea. Biosimilars come from Biocon (Yesafili), Samsung Bioepis (Opuviz), Sandoz (Afqlir, Enzeevu), Formycon (Ahzantive / Baiama), Celltrion (Eydenzelt), Amgen (Pavblu) and Alteogen (Eyluxvi).

Is an aflibercept biosimilar dossier available for licensing? Yes. Aflibercept 2 mg biosimilar dossiers are offered for licensing in EU and US formats. Buyers should check each product's patent and settlement position, because launch dates differ by company and territory.

When can aflibercept biosimilars launch? Amgen's Pavblu has been on the US market since October 2024. Other launches follow settlements, including Yesafili in the US in the second half of 2026, Opuviz in Europe from 2026 and Opuviz in the US in January 2027.

What is the difference between aflibercept and ziv-aflibercept? They are the same molecule. Aflibercept (Eylea) is formulated for injection into the eye, while ziv-aflibercept (Zaltrap) is formulated for intravenous use in colorectal cancer.

What forms and strengths of aflibercept intravitreal are available? Aflibercept is available as a 40 mg/ml solution for a 2 mg dose, in vials or prefilled syringes. A high-dose 8 mg version (Eylea HD) is available from the originator only.