Legal
FTC supports proposed FDA interchangeable biosimilar drug guidance
Agency notes potential marketplace benefits, including a simplified regulatory process, greater patient and provider access as well as increased competition.
Pipeline
Lupin reports positive phase 3 program for Lucentis biosimilar
Global clinical data on LUBT010 determined clinical equivalence between the two, supporting an eventual regulatory submission for FDA approval.
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.
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.
Business
Sandoz completes acquisition of Coherus's ranibizumab biosimilar
Company looks to continue expanding its ophthalmology portfolio.
Legal
Regeneron files lawsuit against potential Eylea biosimilar
Company alleges Celltrion’s CT-P42 biosimilar poses a direct threat to its patented technology.
Pipeline
Sandoz releases positive data on biosimilar aflibercept for wet AMD
Business
Coherus is selling off its ophthalmology franchise to Sandoz
The $170 million deal includes the CIMERLI ophthalmology franchise, an interchangeable biosimilar of LUCENTIS.Legal
Regeneron wins Eylea patent case
Company sued Viatris over patent infringement of a proposed biosimilar in 2022.
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