Pipeline
Alvotech resubmits BLA for proposed Eylea biosimilar
Follows two failed FDA facility inspections; AVT06 will now undergo a 6-month review to become the sixth biosimilar of the name-brand VEGF inhibitor.
Legal
Samsung Bioepis and Regeneron settle EYLEA biosimilar US patent dispute
Settlement and license agreement clears the way for a January 2027 commercial launch of OPUVIZ 2 mg (aflibercept-yszy) injection.
Legal
Regeneron settles with Sandoz over Eylea biosimilar patent infringement lawsuit
Agreement enables FDA-approved Enzeevu (aflibercept-abzv) to launch in Q4 2026, or potentially earlier.
Products
Settlement paves way for US commercialization of Eylea biosimilar
Biocon Biologic’s YESAFILI (aflibercept-jbvf) now expected to launch in H2 2026 after dismissal of Regeneron’s patent infringement lawsuits.
Products
FDA approves Sandoz's EYLEA biosimilar for wet AMD
Approval of Enzeevu (aflibercept-abzv) is expected to be key in growing the company’s U.S. biosimilar-based ophthalmic portfolio.
Products
FDA approves EYLEA biosimilar for serious retinal diseases
Formycon reports the generic biosimilar demonstrates a comparable efficacy, safety, pharmacokinetics, and immunogenicity to Regeneron’s aflibercept.
Legal
Regeneron files lawsuit against potential Eylea biosimilar
Company alleges Celltrion’s CT-P42 biosimilar poses a direct threat to its patented technology.
Products
FDA approves Celltrion's Eylea bisoimilar
EYDENZELT (aflibercept-bvoa) is indicated for patients with wet AMD, macular edema following RVO, DME, and DR.
Business
Harrow purchases US commercialization rights to Samsung Bioepis' biosimilar portfolio
Acquisition includes two major anti-VEGF therapies for retinal diseases: OPUVIZ and BYOOVIZ, generic equivalents to EYLEA and Lucentis, respectively.
Products
FDA approves first interchangeable aflibercept biosimilars
Generic equivalents to Eylea demonstrate a comparable quality, safety, and efficacy profile for wet AMD, DME, RVO, and DR.Legal