Formycon announces EU-Approval of FYB201/Ranivisio®1 a biosimilar to Lucentis®2

Formycon AG / Key word(s): Regulatory Approval
Formycon announces EU-Approval of FYB201/Ranivisio®1 a biosimilar to Lucentis®2

26-Aug-2022 / 16:05 CET/CEST
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Publication of insider information in accordance with Article 17 of the Regulation (EU) No 596/2014 Ad Hoc Announcement // August 26, 2022

Formycon announces EU-Approval of FYB201/Ranivisio^®1 a biosimilar to Lucentis^®2

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announces that the European Commission (“EC”) today has granted marketing authorization (“MA”) for Ranivisio^®, a biosimilar to Lucentis^® (ranibizumab-injection) for medical use in the European Union (“EU”).

FYB201/Ranivisio® was developed by Bioeq, a Joint Venture between Formycon and Polpharma Biologics. Mid 2021, Teva Pharmaceutical Industries Ltd. (“Teva”) entered into a strategic partnership for the exclusive commercialization of FYB201 under the brand name Ranivisio^® in the EU. The commercial launch of Ranivisio® in the EU is planned as soon as possible.

The European Commission now followed the positive opinion issued by the Committee for Medicinal Products for Human Use ("CHMP") in June 2022 and approved Ranivisio^® for the treatment of  neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), the treatment of proliferative diabetic retinopathy (PDR) as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).

The EU-approval is based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. In a randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS-AMD) it was shown that Ranivisio^® is highly similar to the reference product Lucentis^® in terms of comparable efficacy, safety, pharmacokinetics and immunogenicity in patients with age-related neovascular (wet) macular degeneration.

¹⁾ Ranivisio^® is a registered trademark of Bioeq AG
²⁾ Lucentis^® is a registered trademark of Genentech Inc.

About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. Formycon AG is listed in the Open Market ("Scale") of the Frankfurt Stock Exchange (ISIN: DE000A1EWVY8 / WKN: A1EWVY).

About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.

Contact:
Sabrina Müller
Senior Manager Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com

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