Press Releases

Formycon AG today announces that the Brazilian regulatory authority ANVISA has granted marketing authorization for Ranivisio®, a biosimilar to Lucentis® (ranibizumab).

Formycon AG and its commercialization partner Fresenius Kabi proudly announce the market launch of FYB202/Otulfi™ an ustekinumab biosimilar referencing Stelara® in Canada.

Formycon AG and its commercialization partner Fresenius Kabi announce today that the U.S. Food and Drug Administration (FDA) designated FYB202/Otulfi® (ustekinumab-aauz) as interchangeable with the reference biologic Stelara® (ustekinumab).

Formycon AG today reports on the Group’s business development and financial results for the first quarter of fiscal year 2025.

Formycon AG plans to publish its results for the first quarter of 2025 on May 12, 2025. The Management Board will discuss the company’s development, key financial figures, and provide an outlook for the course of 2025.

Formycon AG today published its audited consolidated financial statements for the 2024 financial year and provided an outlook for fiscal year 2025 as well as an assessment of the company’s medium-term development.

Formycon AG (FSE: FYB, “Formycon”) today announced details of the conference call for the release of the fiscal year 2024 results on March 27, 2025.

Formycon AG and its commercialization partner Fresenius announce the commercial availability of Otulfi®, a biosimilar to Stelara® in the United States and the European Union.

Formycon AG and its licensing partner Klinge Biopharma GmbH jointly announce that the UK Medicines and Healthcare products Regulatory Agency has approved FYB203 (aflibercept), a biosimilar to Eylea®, under the brand name AHZANTIVE®.

Formycon AG will present an overview of the comparative data of the ustekinumab biosimilar FYB202 at this year's Congress of the European Crohn's and Colitis Organisation, taking place in Berlin, Germany, from February 19 to 22, 2025.

Formycon AG today provided an update on key developments across various biosimilar projects and invites participants to an extraordinary conference call on February 17, 2025, at 5:00 p.m. CET to share further details regarding these recent events.

Due to the positive feedback from the FDA, the development of FYB206 can continue without a Phase III clinical trial. Increasing and emerging price discounts in the USA are likely to require impairments of FYB201 and FYB202.

Klinge Biopharma GmbH informed Formycon AG, that it has concluded an exclusive license agreement with Lotus Pharmaceutical, a multinational pharmaceutical company, for the commercialization of FYB203/AHZANTIVE® in Asia-Pacific countries: Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam as well as the Special Administrative Region Hong Kong.

Formycon AG and its licensing partner Klinge Biopharma GmbH today jointly announce that the European Commission has granted central marketing authorization for FYB203 (Aflibercept), a biosimilar to Eylea®, under the brand names AHZANTIVE® and Baiama®.

Formycon AG and its commercialization partner Fresenius Kabi announce that the UK Medicines and Healthcare products Regulatory Agency has approved FYB202/Otulfi®(ustekinumab), a biosimilar to Stelara®, for the treatment of moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

Klinge Biopharma GmbH informed Formycon AG about the signing of a licensing agreement with Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. for the semi-exclusive commercialization of FYB203 in major parts of Europe and Israel.

Formycon AG will officially be included in the TecDAX of Deutsche Börse on January 13, 2025

Formycon AG and its commercialization partner Fresenius Kabi announce that Health Canada has issued a “Notice of Compliance” for FYB202/Otulfi® (ustekinumab), a biosimilar to Stelara®

Formycon AG and MS Pharma jointly announce that they have entered into a licensing and supply agreement for the commercialization of FYB202 in the Middle East and North Africa.

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

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

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 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®.

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 AG announced today that it is applying to list its shares on the regulated market (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 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.