Formycon And Fresenius Kabi Announce European Medicines Agency Acceptance Of The Marketing Authorization Application For FYB202, An Ustekinumab Biosimilar Candidate

Formycon AG and its commercialization partner Fresenius Kabi today announced that the European Medicines Agency (“EMA”) has accepted the Marketing Authorization Application (“MAA”) for FYB202, a proposed biosimilar candidate to Stelara.

FYB202 is a human monoclonal antibody that targets interleukin 12 and interleukin 23 for the treatment of immune-mediated disorders. The reference medicinal product Stelara is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis.

“With the current FYB202 submission we are very proud of having brought our third biosimilar pipeline candidate onto the regulatory pathway. The EMA acceptance of the marketing authorization application brings us one step closer to offering broader access to another affordable and important high-quality biosimilar treatment option for patients with chronic immune-mediated inflammatory diseases in Europe,” commented Dr. Stefan Glombitza, CEO of Formycon AG.

“Today marks another milestone in our journey towards advancing healthcare accessibility and the provision of high-quality, affordable treatment options to patients across Europe. The MAA acceptance for review of biosimilar candidate FYB202 is a testament to the dedication and expertise of our teams and the company’s Vision 2026 growth strategy. At Fresenius Kabi, we believe in the power of biosimilars to transform patient care and contribute to the sustainability of healthcare systems,” said Dr. Michael Schönhofen, Fresenius Kabi President Biopharma.

In February 2023, Formycon and Fresenius Kabi entered into a global license agreement to commercialize the proposed ustekinumab biosimilar (FYB202) in key global markets after successful regulatory approvals.

About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has six biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207.

About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2025, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Currently, global sales of biosimilars are estimated at more than $15B. By 2030, analysts estimate that this figure could rise to over $74B.