Press Releases


Information for the media and for our investors

Formycon joins the SDAX of the German Stock Exchange

Formycon AG will join the SDAX of Deutsche Börse, just a few weeks after its successful uplisting to the Prime Standard.


Formycon reports nine-month results for 2024 and continues growth trajectory with further operational success

Formycon today reported on the financial results and business performance of the Formycon Group for the first nine months of fiscal year 2024.


Formycon invites to earnings call on the nine-month results 2024 and announces participation in international investor conferences

Formycon AG invites to the conference call and webcast for the publication of the nine-month results 2024 on November 28, 2024 and will participate in the following international investor conferences in the coming weeks.


Formycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama®

Formycon AG and its licensing partner Klinge Biopharma GmbH jointly announce that the Committee for Medicinal Products for Human Useof the European Medicines Agency issued a positive opinion for the marketing authorization of FYB203, a biosimilar candidate to Eylea®.


Aflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA

Formycon announces that the European Medicines Agency published today that the Committee for Medicinal Products for Human Use issued a positive opinion for market approval for FYB203 / AHZANTIVE®/ Baiama®, a biosimilar candidate to Eylea® (Aflibercept).


Formycon extends Management Board contract for CEO Dr. Stefan Glombitza until 2027 and receives admission to trading in the Prime Standard

Formycon AG announced today that it is applying to list its shares on the regulated market (Prime Standard) of the Frankfurt Stock Exchange.


Formycon applies for admission to the Prime Standard of the Frankfurt Stock Exchange

Formycon AG announced today that it is applying to list its shares on the regulated market (Prime Standard) of the Frankfurt Stock Exchange.


Formycon published results of analytical similarity study of biosimilar candidate FYB206 and Keytruda® in peer-reviewed journal Drugs in R&D

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 and Fresenius Kabi receive FDA approval for FYB202/Otulfi™ (ustekinumab-aauz)

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.


FDA grants approval for Stelara® Biosimilar FYB202/Otulfi™ (ustekinumab-aauz)

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


Formycon and Fresenius Kabi receive European Commission approval for FYB202/Otulfi® (ustekinumab) for the treatment of serious inflammatory diseases

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 will present clinical data on its ustekinumab biosimilar candidate FYB202 at the EADV Congress in Amsterdam and the UEG Week in Vienna

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 reports a strong first half-year with multiple milestones achieved

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.


Formycon invites to conference call on 2024 half-year results and announces participation in international investor conferences

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 increases its outlook for the 2024 fiscal year

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 announces start of clinical phase III trial for Keytruda® biosimilar candidate FYB206

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 and Fresenius Kabi receive positive CHMP opinion for FYB202 (Ustekinumab), a biosimilar candidate to Stelara®

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.


Stelara® Biosimilar Candidate FYB202 (Ustekinumab) receives positive CHMP opinion from EMA

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 receives FDA approval for FYB203/AHZANTIVE®1) (aflibercept-mrbb), a biosimilar to Eylea®2)

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.


FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb)

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 reports on the results of the Annual General Meeting

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


Formycon starts clinical development program for FYB206, a biosimilar candidate for immuno-oncology blockbuster drug Keytruda®

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.


MS Pharma becomes Partner for the Commercialization of FYB203, Formycon’s Biosimilar Candidate to Eylea® (Aflibercept), in the MENA Region

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 reports on successful operating business and financial figures for the first quarter of 2024

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


Formycon invites to the Annual General Meeting on June 12, 2024 in Munich

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 hosts conference call on the results of the first quarter 2024

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


Formycon reports audited annual results for the financial year 2023 – Looking back on a successful operative year and exceeded guidance

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


Formycon invites to the conference call on the results of the financial year 2023 and announces participation in international investor conferences in the 2nd quarter of 2024

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


Convincing overall performance – Formycon reports preliminary results for the financial year 2023 and exceeds forecast

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


Formycon AG publishes preliminary figures for the 2023 financial year and guidance for the 2024 financial year

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 announces commercial launch of FYB201 (Ranibizumab) in Canada (RanoptoTM) and Switzerland (Ranivisio®)

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


Formycon and Fresenius Kabi reach settlement agreement for ustekinumab biosimilar candidate FYB202 in Europe and Canada

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.


FYB201/Ranibizumab keeps gaining momentum with approvals and launches in the MENA region

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


Gedeon Richter becomes strategic investor of Formycon via equity investment

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.


Formycon resolves on cash capital increase of EUR 82.84 million – all new shares were subscribed by Gedeon Richter as new strategic investor

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 Ranibizumab Biosimilar FYB201/CIMERLI® achieved a market share of 38% in the United States in December 2023

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


Formycon to present at the 42nd Annual J.P. Morgan Healthcare Conference

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).