Press Releases

Formycon AG announced today that the patient enrollment for the clinical PK study Dahlia has been successfully completed with a total of 96 participants (Last Patient-In).

Formycon AG today announces that Bioeq AG, licensee and exclusive holder of the worldwide commercialization rights for FYB201, Formycon's biosimilar for Lucentis® (ranibizumab), entered into an exclusive partnership with African biotechnology company Bio Usawa Biotechnology Ltd.

Formycon AG announces that its 2025/2029 corporate bond was significantly oversubscribed due to high demand, leading to an increase in the initially targeted issuance volume from EUR 50 million to EUR 70 million. The senior unsecured and floating rate bond with a term of four years was successfully and entirely placed on the capital market.

The management board of Formycon AG today successfully placed a senior unsecured floating rate bond in a total volume of EUR 70 million.

Formycon AG announces that it has entered into a distribution agreement with ratiopharm GmbH, a subsidiary of the Teva Group, for the semi-exclusive commercialization of its Stelara® biosimilar FYB202/Fymskina® in Germany.

Formycon AG today announces that Klinge Biopharma GmbH, the exclusive owner of the global commercialization rights of FYB203/AHZANTIVE® (aflibercept-mrbb), Formycon’s biosimilar to Eylea®, concluded an exclusive license agreement with U.S. biosimilars specialist Valorum Biologics LLC for the commercialization of FYB203/AHZANTIVE® in the United States and Canada.

Formycon AG today announced that strong demand, particularly from institutional investors, for its 2025/2029 corporate bond has led to the public offering period ending ahead of schedule.

The announced corporate bond of Formycon AG has met with great interest, particularly among institutional investors. Due to the strong demand, the offer period of the public offer of the Bond will be shortened.

Formycon AG (FSE: FYB, Prime Standard, “Formycon”) announces that investors can now subscribe to the 2025/29 corporate bond (ISIN: NO0013586024 / WKN: A4DFJH) via Deutsche Börse's ‘DirectPlace’ subscription service. This service allows interested investors to place purchase orders directly with their house bank or custodian bank on the Frankfurt Stock Exchange during the subscription period.

Formycon AG announces that the securities prospectus for the newly issued corporate bond 2025/2029 has been approved by the Luxembourg financial supervisory authority (CSSF) on June 17, 2025, and that investors can now subscribe to the bond via the company’s website.

Formycon AG today decided to issue a four-year corporate bond with a target volume of EUR 50 million.

The Management Board of Formycon AG today resolved, with the approval of the Supervisory Board, to examine the possibility of issuing a public senior unsecured, floating rate corporate bond with a target volume of EUR 50 million to support its ongoing growth strategy.

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®