On 2 April 2026, Biocon filed a petition for post grant review (PGR) of Regeneron’s patent US12168036 entitled “Methods for Treating Angiogenic Eye Disorders with High Doses of VEGF Receptor Fusion Proteins”.
Biocon’s petition seeks to join Alvotech’s pending PGR in relation to the same patent. Alvotech’s PGR petition was filed on 17 September 2025 and the PGR was instituted by the Patent Trial and Appeal Board on 3 March 2026. Biocon’s PGR petition is substantially the same as that filed by Alvotech.
Regeneron’s ‘036 patent relates to methods for treating an angiogenic eye disorder by intravitreal administration of about 100 microlitres or less of at least about 8mg of a VEGF receptor fusion protein in a formulation with a particular viscosity. Both Biocon’s and Alvotech’s PGR petitions argue that the claims of the ‘036 patent are invalid for obviousness and lack of written description.
High dose Eylea® is approved in the US (as Eylea HD®) for wet age-related macular degeneration, diabetic macular oedema, diabetic retinopathy (August 2023) and retinal vein occlusion (November 2025). It is also approved in other jurisdictions (as Eylea™ 8mg), including Europe (January 2026), the UK (February 2026) and Korea (February 2026). Eylea™ 8mg pre-filled syringe (OcuClick™) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025).
Alvotech is developing AVT29, a biosimilar to Regeneron/Bayer’s Eylea HD®. In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 in Europe. Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US. Alvotech has recently indicated that it expects to file the first regulatory submission for AVT29 sometime in 2026.
Biocon has not yet announced that it has a high dose Eylea® biosimilar in development. Biocon’s Yesafili™ was one of the first approved interchangeable aflibercept (2 mg) biosimilars in the US in May 2024. Biocon and Regeneron settled US BPCIA litigation regarding aflibercept (2 mg) in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026, or earlier under certain undisclosed circumstances.