DGAP-Ad-hoc: Formycon AG / Key word(s): Regulatory Approval/Product Launch
Publication of insider information in accordance with Article 17 of the Regulation (EU) No 596/2014 Ad Hoc Announcement // August 3, 2022
Formycon announces FDA approval of FYB201/CIMERLITM1 (ranibizumab-eqrn) as a Biosimilar interchangeable with Lucentis®2
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announces 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 AG, a Joint Venture between Formycon AG and Polpharma Biologics Group BV. 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 of America (“U.S.”). The commercial launch of CIMERLI™, in both 0.3mg and 0.5mg dosages, in the U.S. by Coherus, is planned for early October 2022.
CIMERLI™ obtained approval from 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 month 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. 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).
1) CIMERLI™ is a trademark of Coherus BioSciences, Inc.
2) Lucentis® is a registered trademark of Genentech Inc.
03-Aug-2022 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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1411891 03-Aug-2022 CET/CEST