Press Releases

Formycon AG announced today that the results of the comparative analytical evaluation of the proposed pembrolizumab biosimilar FYB206 and the immuno-oncology blockbuster drug Keytruda®1 were published in Drugs in R&D, an international, peer-reviewed journal owned by Springer.

Formycon AG and its commercialization partner Fresenius Kabi jointly announce that the FDA has approved FYB202/Otulfi™ (ustekinumab-aauz), a biosimilar to Stelara®, for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

Formycon AG announces that the U.S. Food and Drug Administration (FDA) today approved FYB202/OtulfiTM (ustekinumab-aauz), a biosimilar to Stelara®.

Formycon AG and its commercialization partner Fresenius Kabi jointly announce that the European Commission (EC) has issued a marketing authorization for FYB202/Otulfi®, a biosimilar to Stelara®

Formycon AG will present clinical study data of its ustekinumab biosimilar candidate FYB202 at this year's European Academy of Dermatology & Venerology (EADV) congress.

Formycon AG today published its consolidated financial report for the first six months of fiscal year 2024, providing an update on the company's business performance.

Die Formycon AG today announced details for the financial and earnings conference call for the first half of the 2024 fiscal year on August 13, 2024.

Formycon AG has today decided, based on the preliminary half-year figures, to raise its guidance for the 2024 fiscal year. This affects the key figures adjusted EBITDA and working capital.

Formycon AG announced today that the first patient has been enrolled in the Phase III clinical trial “Lotus” to compare the safety and efficacy of FYB206/pembrolizumab with the immuno-oncology blockbuster drug Keytruda®.

Formycon AG and its commercialization partner Fresenius Kabi jointly announce, that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for the marketing authorization of FYB202, a biosimilar candidate to Stelara®, indicated for the treatment of several serious inflammatory diseases.

Formycon AG announces that the Committee for Medicinal Products for Human Use of the European Medicines Agencytoday issued a positive opinion for FYB202, a biosimilar candidate to Stelara® (Ustekinumab).

Formycon AG and its licensing partner Klinge Biopharma GmbH jointly announce that the U.S. Food and Drug Administration approved FYB203/AHZANTIVE® (aflibercept-mrbb), a biosimilar to Eylea®, on June 28, 2024.

Based on preliminary and unaudited figures for the 2023 financial year, Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) ("Company") expects EBITDA to be around EUR 1.5 million (guidance: EUR -5 million to EUR -15 million)

Formycon AG held its Annual General Meeting on 12 June 2024 as an in-person event in Munich.

Formycon AG announced today that the clinical development program for FYB206, a biosimilar for Keytruda® / pembrolizumab, has started with the inclusion of the first patient.

Klinge Biopharma GmbH, licensee and exclusive holder of the worldwide commercialization rights for FYB203, Formycon's biosimilar candidate to Eylea®, has entered into an exclusive licensing and supply agreement with MS Pharma for the commercialization of FYB203 in the Middle East and North Africa

Formycon AG today published figures for the first quarter of financial year 2024.

Formycon published the invitation to its Annual General Meeting on Wednesday, June 12, 2024. The Annual General Meeting will be held as an in-person event for shareholders and their proxies from 11 a.m. (CEST) at the Haus der Bayerischen Wirtschaft in Munich.

Formycon AG today announced details of the conference call to release the results of the first quarter 2024 on May 08, 2024.

Formycon AG today published audited figures and the annual report for the 2023 financial year and provides an outlook for 2024.

Formycon AG today announced details of the conference call to release the results of the financial year 2023 on April 25, 2024.

Formycon AG today announced preliminary, unaudited consolidated figures for the 2023 financial year and overall looks back on the past year very positively.

Based on preliminary and unaudited figures for the 2023 financial year, Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) ("Company") expects EBITDA to be around EUR 1.5 million (guidance: EUR -5 million to EUR -15 million)

Formycon and Bioeq announce the commercial launch of FYB201, a biosimilar to Lucentis® (Ranibizumab), in Canada and Switzerland.

Formycon AG and its commercialization partner Fresenius Kabi today announced the signing of a settlement agreement with Johnson & Johnson concerning the commercialization of FYB202 in Europe and Canada.

Formycon AG and MS Pharma announced today that FYB201, a biosimilar to Lucentis® (Ranibizumab), has received marketing authorization from the Saudi Food & Drug Authority

Formycon AG today announced that Hungary based specialty pharmaceutical company Gedeon Richter Plc. becomes strategic investor via cash capital increase from authorized capital in the amount of 9.08% of Formycon’s share capital.

Today, the management board of Formycon AG, with the consent of the Company's supervisory board, resolved to increase the Company's share capital against cash contributions by issuing new no par-value bearer shares of the Company, partially utilizing the authorized capital and excluding the shareholders' subscription rights.

Formycon AG today announced that its commercialization partner, Coherus BioSciences, Inc. has released new sales figures for CIMERLI® in the US.

Formycon AG today announced that Formycon CEO Dr. Stefan Glombitza will present at the upcoming 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 09, 2024, at 8:15 a.m. PT (5:15 p.m. CET).