Coherus Biosciences has acquired an aflibercept biosimilar; the FDA has sent Biocon Biologics a complete response letter (CRL) regarding its insulin biosimilar; Lannett provides an update on the development of its insulin glargine and insulin aspart biosimilars.
Coherus Biosciences has acquired the US commercial rights for an aflibercept biosimilar, the FDA has sent Biocon Biologics a complete response letter (CRL) regarding its insulin biosimilar, and Lannett provides an update on the development of its insulin glargine and insulin aspart biosimilars.
Coherus Acquisition of Aflibercept Biosimilar
Coherus has announced that it would acquire the exclusive US commercial rights to FYB203, an aflibercept biosimilar referencing Eylea, from Klinge Biopharma.
The companies anticipate the transaction to complete during the first quarter of 2023, and Coherus will be responsible for filing a biologics license application (BLA) for the biosimilar to the FDA for approval. If approved, Coherus said that it intends to launch the product in 2025.
Aflibercept is used to treat neovascular age-related macular degeneration (wet AMD), macular edema, diabetic macular edema, and myopic choroidal neovascularization. Klinge Biophama had in-licensed FYB203 from Formycon. FYB203 is currently being investigated in a phase 3 randomized, double-blind, multicenter study comparing the safety and efficacy profiles between the biosimilar and the reference product.
The researchers recruited 434 patients with wet AMD. The participants will receive 1 intravitreal injection of the biosimilar every 4 weeks for the first 3 doses followed by 1 injection every 8 weeks through study completion.
Biocon Biologics Receives CRL
Biocon, the parent company of the Bengaluru, India–based Biocon Biologics, shared that the company received a CRL from the FDA conserving its recombinant insulin biosimilar.
The CRL called for additional data to be submitted and an “expectation of a satisfactory implementation of a [Corrective and Preventive Actions] plan pertaining to the pre-approval inspection” of their manufacturing facilities in August 2022.
A company spokesperson at Biocon Biologics said that the company is in the process of addressing the letter.
Lannett Updates on Insulin Biosimilar Development
Lannett provided updates on the clinical development of 2 insulin biosimilars: an insulin glargine and an insulin aspart. The company is developing the biosimilar candidates as part of a partnership with the HEC Group of companies.
The updates from a preclinical study comparing the biosimilar insulin aspart with the US version of the reference product (NovoLog) demonstrated that the products were highly comparable. The data will be submitted to the FDA as part of Lannett’s request for approval, which it expects to file during the end of 2024, with a potential launch in 2025.
Comments from Tim Crew, CEO of Lannett, claimed that studies for the biosimilar insulin glargine are ongoing, and results are expected to be available by the end of February 2023. The need for equipment maintenance and recalibration led to a 2 month delay in the study, and researchers were able to complete it by the UK-based lab’s planned end-of-year shutdown. Crew said that Lannett anticipated filing a BLA in midyear 2023 and aims to launch the product during the first half of 2024.