On occasion, we profile some biosimilar manufacturers about whom our readers may not be as familiar as the large players like Sandoz, Amgen, and Pfizer. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight a German company, named Formycon AG.
Formycon acquired Scil Technology GmbH in 2012, and hired a new CEO the following year. Carsten Brockmeyer, PhD, has extensive experience in the biosimilar field, previously helping Hexal Biotech to develop EPO and filgrastim biosimilars for the European market. Dr. Brockmeyer has been refocusing Formycon in this direction as well. Currently this Munich-based organization has about 70 employees and a market capitalization of approximately €210 million according to Formycon.
Why you may be hearing more about this company: Formycon has been working at getting ahead of the biosimilar curve, announcing its intention to develop and market its version of ustekinumab when Stelara®’s patent expires in 2023 (US) and 2024 (Europe). It is not currently lined up with a partner on the manufacture, testing, or marketing of this interleukin 12/23 inhibitor (also known as FYB 202). Although this biosimilar is in the preclinical stage, Formycon does have another that is nearing the starting line: its version of ranibizumab (FYB 201) is the focus of a pivotal phase 3 study (in partnership with Bioeq GmbH) in Germany. It is scheduled to be completed in 2020, but the initial data from the total 650 patients may well be evaluated by an earlier date).
It should be noted that in many countries, including the US, off-label use of bevacizumab for the treatment of age-related wet macular degeneration is considered far more cost effective than the originator product Lucentis®, and it has equivalent outcomes. Therefore, the biosimilar market for ranibizumab is somewhat limited. However, Formycon is also beginning preclinical investigation of a biosimilar for Eylea (aflibercept or FYB 203), the next generation of macular degeneration treatment. It is partnered with Santo Holding GmbH on the development of aflibercept.