Munich – Formycon AG, the biosimilar drug development company, has completed a successful GMP (Good Manufacturing Practices) inspection of its site in Munich-Martinsried by the Government of Upper Bavaria. The German GMP certificate confirms that Formycon conducts analytical testing in compliance with EU GMP regulations and underlines Formycon’s position as integrated biosimilar development company. This achievement is another important step in Formycon’s preparation of the pivotal phase III study of clinical testing for its first biosimilar candidate (FYB201) which already has been licensed out to Santo Holding GmbH back in December 2013.
Furthermore, the company has received final advice in December 2014 from the European Medicines Agency (EMA) in London for the non-clinical and clinical development of FYB201. EMA’s scientific experts are in consensus with Formycon’s approach to move FYB201 directly into phase III clinical testing, which puts Formycon almost one year ahead.
Formycon has now submitted the clinical study protocol and other documents to the U.S. Food and Drug Administration (FDA) to obtain also FDA’s expert advice before starting the pivotal global phase III study.
Background: What are biosimilars?
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. In the coming years, many of the patents for these biotech drugs will expire – and by the year 2020, medications with revenues of more than USD 100 billion will lose their patent protection. In this way, it will become possible to launch new competing drugs, known as “biosimilars”. While the global market for these new-generation drugs is currently some USD 2.5 billion, industry experts expect this figure to grow tenfold by the year 2020. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise.