Polpharma Biologics Group BV (“Polpharma Biologics”), Formycon AG (“Formycon”) and Bioeq AG (“Bioeq”), have jointly announced that the U.S. Food and Drug Administration (“FDA”) has approved CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection).
FYB201 was developed by Bioeq, a Joint Venture between Polpharma Biologics and Formycon. End of the year 2019, Coherus BioSciences, Inc. (“Coherus”) entered into a license agreement for the exclusive commercialization of FYB201 under the brand name CIMERLI™ in the United States
CIMERLI™ obtained approval from the FDA for the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema following Retinal Vein Occlusion (RVO) and Myopic Choroidal Neovascularization (mCNV). CIMERLI™ is the first and only interchangeable biosimilar with an exclusivity for 12 months after market launch that is indicated for the treatment of all five Lucentis® indications and, as such, is a new medical option for patients with serious retinal diseases.
FDA-approval and interchangeability designation are based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. The efficacy, safety, pharmacokinetics and immunogenicity of CIMERLI™ were found to be comparable to the reference drug Lucentis® in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD). Clinical readouts from the randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS AMD) have been published in the peer-reviewed journal, Ophthalmology.
CIMERLI™ belongs to the anti-VEGF therapy class of biologics that have been revolutionary in helping retinal patients in maintaining or regaining vision. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. The commercial launch of CIMERLI™ in the U.S by Coherus, is planned for early October in both 0.3mg and 0.5mg doses.
Read the full press release from Polpharma Biologics.
Source: Polpharma Biologics