FYB206 is a biosimilar candidate for Keytruda® (pembrolizumab). Keytruda®* is used in cancer immunotherapy for the treatment of various tumor diseases.
Current development status
Clinical phase I
Clinical phase III
Klinische Phase III
Scope of therapeutic indication
The active ingredient pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. Pembrolizumab binds to the PD-1 receptor and specifically blocks the interaction between PD-1 and its ligand PD-L1. This helps the immune system to activate the body’s own cellular anti-tumor immune response and kill melanoma cells, for example.
The specific mechanism of PD-1 blockade is not limited to one type of cancer, but is effective in numerous oncological indications. In addition to advanced melanoma (black skin cancer), pembrolizumab is indicated for non-small cell lung cancer and classical Hodgkin’s lymphoma (malignant disease of the lymphatic system). Non-small cell lung cancer is one of the most common cancer indications worldwide. In Germany alone, 50,000 people are diagnosed with the disease every year.
Our development work
The FYB206 project has reached important development stages in process development and the preclinical phase. Following convincing results from the extensive analytical characterization of the developed molecule as well as significant progress in the development of the manufacturing process, a comprehensive data package is currently being compiled in order to closely coordinate further program steps in Scientific Advice Meetings with the EMA and FDA in the second half of the year.
Important IP has already been established and patented, including the development of alternative formulations.
In 2022, the reference market for Keytruda® was reported to be over USD 20.9 billion worldwide.[i] Leading data-driven and expert analyses predict that Keytruda® will be the world’s top-selling drug in 2023.[ii]
Following the Scientific Advice Meetings with the EMA and FDA scaling up of the manufacturing process to commercial scale is planned for the end of 2022. For this purpose, Formycon secured GMP manufacturing capacity at an experienced and established manufacturer at an early stage.
Our goal is the product launch in the US and the EU when patent protection for the reference product expires.
* Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.