FYB206


Pembrolizumab biosimilar candidate

FYB206 is a biosimilar candidate for Keytruda® (pembrolizumab). Keytruda®* is used in cancer immunotherapy for the treatment of various tumor diseases.

Reference

Keytruda®


Indication

Immuno-oncology


Partner

not partnered


Current development status

Preclinical phase
Clinical phase I
Clinical phase III
Submission
Approval

Entwicklungsstand

Präklinische Phase
Klinische Phase III
Zulassungsantrag
Zulassung

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.


The market


In 2021, the reference market for Keytruda® was reported to be over USD 17 billion worldwide.[i] Leading data-driven and expert analyses predict that Keytruda® will be the world’s top-selling drug in 2023, with annual revenue potential expected to be well over USD 20 billion as early as 2025.[ii]


Next milestones

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.

 


 

[i] Statista Revenue of Keytruda from 2014 to 2021 Keytruda revenue 2014-2021 | Statista. Retrieved September 2022

[ii] Best-selling drugs of the next 5 years  The best-selling drugs of the next 5 years – Pharma Excipients; Merck, BMS, AbbVie blockbusters will rule pharma sales in 2025: report | Fierce Pharma. Retrieved September 2022