Coherus and Xbrane Announce Acceptance of Regulatory Submissions for Ranibizumab Biosimilars

On October 1, 2021, Coherus BioSciences announced that FDA has accepted for review Coherus’ BLA for CHS-201, a candidate biosimilar to Lucentis® (ranibizumab), which is indicated for neovascular age-related macular degeneration (nAMD) and several other ophthalmic conditions. The BLA was originally submitted by Coherus’ partner, BioeqAG.  On October 4, 2021, Coherus announced positive results from a phase 3 clinical trial that demonstrated similarity of CHS-201 and Lucentis® in terms of clinical efficacy, safety, and immunogenicity for treatment of nAMD.  According to Coherus, the company plans to launch its ranibizumab biosimilar in the United States in the second half of 2022.

On September 30, Xbrane Biopharma announced that EMA had validated the marketing authorization application for a ranibizumab biosimilar candidate that was filed by Xbrane’s development partner, STADA Arzneimittel AG.