Munich – The biosimilars company Formycon has today announced details of a further product from its development pipeline. FYB202 is a biosimilar candidate for Stelara®* (ustekinumab) which is currently in the pre-clinical testing phase. This means that Formycon’s development pipeline comprises FYB201 (biosimilar candidate for Lucentis®**), FYB203 (biosimilar candidate for Eylea®***) and FYB202 (biosimilar candidate for Stelara®), three of the highest-selling drugs from the third wave of biosimilars which addresses reference products set to lose their legal protection after 2020.
Stelara® (ustekinumab) is a human monoclonal antibody that targets the cytokines interleukin-12 and Interleukin-23. Since 2009, the drug has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis. In 2016, its indications were extended, allowing Stelara® to also be used for the treatment of Crohn’s disease, a chronic inflammatory condition of the bowel.
In recent years, Stelara® has brought growing revenues and in 2016 achieved global sales of around US$ 3.2 billion. Further sales growth is also anticipated for the future. According to information from the US National Center for Biotechnology Information (NCBI) and the World Health Organization (WHO), the psoriasis market is set to increase by an average of 7.3 percent per year, reaching a volume of US$ 13.3 billion by 2024. For Crohn’s disease, an expansion of the market from its current level of US$ 3.5 billion to US$ 4.4 billion is expected over the same period. There may also be further potential for sales through the possible approval of Stelara® for additional indications, for example the treatment of other serious gastrointestinal conditions. Marketing of a biosimilar for Stelara® should become possible towards the end of 2023 in the USA and from the middle of 2024 in Europe once the legal protections expire.
Dr. Carsten Brockmeyer, board member and CEO of Formycon, regards the biosimilar candidate for Stelara® as a further important milestone on Formycon AG’s journey towards becoming a leading company in the promising biosimilar industry: “The costs of treating chronic conditions such as psoriasis and Crohn’s disease have become a major challenge for healthcare systems around the world. With the development of the Stelara® biosimilar, we are pursuing the goal of offering this treatment to doctors and patients at an affordable price, thereby increasing access to this important drug and at the same time allowing urgently needed savings to be made in healthcare systems.”
Dr. Stefan Glombitza, board member and COO of Formycon, adds: “For the sophisticated development of the biosimilar product FYB202, we will build on our first-class scientific expertise, strict development standards and efficient cooperation with renowned third-party manufacturers in order to achieve our milestones with the final goal of getting biosimilar approval from international authorities. Our team is highly motivated by the fact that through our product development we will be able to create broader access to high-quality medication for the many patients with psoriasis and Crohn’s disease.”
* Stelara is registered trademark of Johnson & Johnson
** Lucentis is a registered trademark of Genentech Inc.
*** Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.
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 four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of an innovative COVID-19 drug FYB207.
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 2020, 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. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.