Press Releases
Information for the media and for our investors
Bio Usawa becomes partner for the commercialization of FYB201/BioUcenta™ (ranibizumab) across Sub-Saharan Africa
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.
July 1, 2025
Formycon increases bond volume following oversubscription – Bond 2025/2029 with a volume of EUR 70 million successfully and entirely placed
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.
June 27, 2025
Formycon successfully places an EUR 70 million senior unsecured floating rate bond
The management board of Formycon AG today successfully placed a senior unsecured floating rate bond in a total volume of EUR 70 million.
June 27, 2025
Teva becomes secondary commercialization partner for Formycon’s Stelara® biosimilar FYB202 (ustekinumab) under the brand name Fymskina® in Germany
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.
June 26, 2025
U.S. biosimilar specialist Valorum Biologics LLC becomes commercialization partner for Formycon’s Eylea® biosimilar FYB203/AHZANTIVE® (aflibercept-mrbb) in the United States and Canada
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.
June 25, 2025
Strong demand for Formycon 2025/2029 Bond leads to early closing of subscription period
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.
June 24, 2025
Early end of the offer period for the bond due to high demand
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.
June 24, 2025
Formycon bond 2025/2029: Public subscription now also possible via Deutsche Börse
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.
June 20, 2025
Ordinary Annual General Meeting of Formycon AG approves all proposed resolutions by large majorities
Formycon AG held its Annual General Meeting on 18 June 2025 as an in-person event in Munich. In its presentation, the Management Board provided shareholders with a detailed report on the company's development and answered all questions in the general debate.
June 18, 2025
Subscription period for 2025/2029 corporate bond has started
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.
June 18, 2025
Formycon plans public corporate bond issuance to support next growth phase within attractive Biosimilar markets
Formycon AG today decided to issue a four-year corporate bond with a target volume of EUR 50 million.
June 17, 2025
Formycon plans to issue a public senior unsecured floating rate bond with target volume of EUR 50 million to support further company growth
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.
June 17, 2025
Lucentis® biosimilar FYB201/Ranivisio® (ranibizumab) approved in Brazil
Formycon AG today announces that the Brazilian regulatory authority ANVISA has granted marketing authorization for Ranivisio®, a biosimilar to Lucentis® (ranibizumab).
June 5, 2025
Formycon and Fresenius Kabi announce the commercial launch of FYB202/Otulfi™, an approved ustekinumab biosimilar, in Canada
Formycon AG and its commercialization partner Fresenius Kabi proudly announce the market launch of FYB202/Otulfi™ an ustekinumab biosimilar referencing Stelara® in Canada.
May 27, 2025
Formycon and Fresenius Kabi announce FDA Approval of Interchangeability for FYB202/Otulfi® (ustekinumab-aauz)
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).
May 19, 2025
Formycon reports strong operational performance and financial results for first quarter of 2025
Formycon AG today reports on the Group’s business development and financial results for the first quarter of fiscal year 2025.
May 12, 2025
Formycon invites to conference call on the results of the first quarter of 2025 and announces participation in international investor conferences
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.
May 7, 2025
Formycon reports on a successful financial year 2024 with strong operational progress and continuous strengthening of its market position
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.
March 27, 2025
Formycon invites to conference call on the results of the financial year 2024 and announces participation in international investor conferences in the 2nd quarter of 2025
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.
March 24, 2025
FYB202/Otulfi® (ustekinumab-aauz), a biosimilar to Stelara®, launched in the United States and the European Union
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.
March 3, 2025
Formycon receives regulatory approval in the UK for FYB203 (aflibercept), a biosimilar to Eylea®, under the brand name AHZANTIVE®
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®.
February 25, 2025
Formycon presents clinical data on ustekinumab biosimilar FYB202 at the ECCO Congress in Berlin
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.
February 20, 2025
Formycon AG informs about recent developments in various biosimilar projects and invites to conference call
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.
February 17, 2025
Formycon announces decision on Phase III trial with FYB206 and provides update on potential need to adjust the valuation of FYB202 and FYB201
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.
February 17, 2025
Lotus Pharmaceutical becomes strategic partner for the commercialization of Formycon’s Eylea® biosimilar FYB203/AHZANTIVE® in the Asia-Pacific Region
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.
February 5, 2025
Formycon receives EU approval for FYB203 (aflibercept), a biosimilar to Eylea®, under the brand names AHZANTIVE® and Baiama®
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®.
January 20, 2025
Formycon and Fresenius Kabi announce MHRA approval for FYB202/Otulfi® (ustekinumab), a biosimilar to Stelara®
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.
January 15, 2025
Teva becomes strategic commercialization partner for Formycon’s biosimilar candidate FYB203 (Eylea®/ aflibercept) in major parts of Europe and Israel
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.
January 13, 2025
Formycon included in TecDAX Index of Deutsche Börse
Formycon AG will officially be included in the TecDAX of Deutsche Börse on January 13, 2025
January 9, 2025
Formycon and Fresenius Kabi Canada receive Health Canada’s approval for FYB202/Otulfi® (ustekinumab), a biosimilar to Stelara®
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®
January 8, 2025
MS Pharma becomes Partner for the Commercialization of FYB202 / ustekinumab in the MENA Region
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.
December 9, 2024
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.
December 5, 2024
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.
November 28, 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.
November 19, 2024
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®.
November 18, 2024
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).
November 15, 2024
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.
November 11, 2024
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.
November 4, 2024
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.
October 16, 2024
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.
September 30, 2024
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®.
September 27, 2024
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®
September 27, 2024
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.
September 17, 2024
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.
August 13, 2024
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.
August 7, 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.
August 6, 2024
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®.
July 30, 2024
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.
July 26, 2024
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).
July 26, 2024
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.
July 1, 2024