DGAP-News

Formycon and Bioeq announce Launch of Phase III Study of FYB202, a Biosimilar Candidate for Stelara(R)* (Ustekinumab) - Seite 2

FYB202 is being developed as part of a joint venture between Aristo Pharma GmbH and Formycon AG, as well as in cooperation with bioeq GmbH. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US Food and Drug Administration (FDA) and the European regulatory authority (EMA).

Formycon's COO Dr. Stefan Glombitza is pleased: "With the start of what is now our third clinical Phase III study, we have reached another milestone in the development of our (late-stage) biosimilar candidates. With FYB202 we have a promising biosimilar candidate and are addressing an important and growing market in the inflammatory diseases segment. We would also like to thank our partners for their constructive cooperation and look forward to further joint steps towards the approval of our high-quality Stelara(R) biosimilar."

^* Stelara(R) is a registered Trademark of Johnson & Johnson

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 four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of antibody-based COVID-19 compounds.

About Bioeq:
Bioeq was founded in 2014 and is a leading service provider in the development of biopharmaceutical follow-on products, known as biosimilars. Working with various partners, Bioeq develops third-wave biosimilars and specializes in ophthalmic agents. The development programs meet the standards for highly regulated markets such as Europe, the USA, Canada, or Japan, and are therefore suitable for global licensing. Bioeq's expertise lies primarily in comprehensive project management, clinical development, the drafting of licensing strategies in dialog with the authorities, the development of application systems for administering the products, the drawing-up of patent strategies, and in license management. Bioeq is currently working on five different biosimilar projects.