Formycon

Formycon AG is a German biopharmaceutical company specializing in the development of biosimilars, which are highly similar versions of approved biological drugs. The company focuses on creating high-quality biosimilars for various therapeutic areas, with a particular emphasis on ophthalmology. Formycon's product pipeline includes biosimilar candidates for established drugs such as Lucentis (ranibizumab), Stelara (ustekinumab), and Eylea (aflibercept). These biosimilars are designed to treat conditions like wet macular degeneration, psoriasis, and other age-related eye diseases.

The company's development process involves extensive research, formulation, and clinical trials to ensure the efficacy and safety of its biosimilar candidates. Formycon has successfully initiated and completed various phases of clinical trials for its products. For instance, in January 2016, Formycon and its partner bioeq GmbH announced the initiation of a pivotal Phase III clinical trial for FYB201, a biosimilar candidate for ranibizumab. The company has also made progress with other candidates, such as FYB202 (ustekinumab biosimilar) and FYB203 (aflibercept biosimilar).

In addition to its biosimilar portfolio, Formycon has expanded its research into innovative drug development. In response to the Covid-19 pandemic, the company began developing FYB207, an antibody-based drug for treating SARS-CoV-2 infections. This project received funding from the Bavarian Research Foundation and demonstrated promising results in preclinical studies.

Formycon has also focused on improving drug delivery systems. In January 2016, the company filed patent applications for silicone-free pre-filled plastic syringes designed for the intraocular delivery of VEGF antagonists. This innovation aims to enhance safety and convenience for patients and healthcare professionals in the administration of eye treatments.

Key customers and partnerships

Formycon has established several strategic partnerships to advance its product development and commercialization efforts. In February 2023, the company signed a licensing deal with Fresenius Kabi for the distribution of its biosimilar FYB202. Formycon has also partnered with Teva Pharmaceutical for the commercialization of FYB201 in Europe, Canada, Israel, and New Zealand, as announced in March 2021.

Formycon has also collaborated with academic institutions. In February 2021, Formycon and scientists from the Technical University of Munich (TUM) published new data on FYB207, highlighting the company's commitment to advancing scientific research in drug development.