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
Entwicklungsstand
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
After establishing the manufacturing process and aligning the study design with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), Formycon announced the start of the Phase I clinical trial with the “first patient in” on June 13, 2024. This makes Formycon one of the first three biosimilar developers to announce entry into the clinical development phase for the EU and US markets.
The Phase I study compares the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference drug Keytruda® in patients who have had surgery to remove malignant melanoma (black skin cancer). Recruitment for the parallel Phase III clinical trial is also expected to start very soon.
Important IP has already been established and patented, including the development of alternative formulations.
The market
With its broad range of indications in oncology and sales of USD 25 billion in 2023[i], Keytruda® is currently the world’s best-selling drug. Due to the increasing number of cancers diagnoses around the world – the International Agency for Research on Cancer (IARC) predicts an increase of 77% by 2050[ii] – further growth in sales are forecasted for pembrolizumab over the coming years.
Next milestones
Following the successful start of the Phase I clinical trial, the parallel Phase III clinical trial is also expected to start very soon. The Phase III trial will compare the safety and efficacy of FYB206 with the reference drug Keytruda® in patients with non-small cell lung cancer.
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] Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results – https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2023-financial-results/
[ii] World Health Organization (WHO): Global cancer burden growing, amidst mounting need for services – https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing–amidst-mounting-need-for-services