Formycon - Two submissions and two Phase III trials in 2021
Formycon continues to progress three core biosimilar projects. In H220, it is preparing the FYB201 (Lucentis biosimilar) EMA approval submission and helping in the resubmission of FYB201 to the FDA. FYB203 (Eylea biosimilar) entered Phase III in August. FYB202 (Stelara biosimilar, autoimmunity) is due to enter Phase III imminently. Development income from partners was €16.5m in H120, giving a loss of €1.4m and a cash outflow of €2.1m. Cash was €20.3m on 30 June.Formycon AG is a Germany-based company engaged in providing biosimilar drugs and formulations. Its business activities are focused on the development and marketing of biopharmaceuticals that are similar to existing drugs, for which the patent protection is expiring. The Company focuses on treatments in the area of ophthalmology, immunology and other chronic diseases, covering all steps of biosimilar development process, from early-stage analysis of the originator drug to the preclinical and clinical testing phases, as well as the preparation of dossiers for marketing approval. Its biosimilar product pipeline consists of four candidates in pre-clinical and clinical testing phases, including FYB201, a biosimilar candidate for Lucentis; FYB202, a biosimilar candidate for Stelara; FYB203, a biosimilar candidate for Eylea, and FYB205.
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