- Positioning in the field of immuno-oncology with the biosimilar candidate FYB206
- Addressable market size expected to be well above USD 20 billion after patent expiries from 2028 onwards
- With a patent application for a proprietary formulation important intellectual property (IP) has already been created
- Development of the manufacturing process is at an advanced stage and GMP manufacturing capacities have been secured
Formycon AG today announced details of a previously undisclosed project in its development pipeline. FYB206 is a biosimilar candidate for Keytruda (pembrolizumab) and the development is at an advanced preclinical stage. In addition to biosimilars in the field of ophthalmology (FYB201/FYB203), immunology (FYB202) and two further yet unpublished biosimilar candidates (FYB208/FYB209), Formycon is expanding its therapeutic range with FYB206 to the rapidly growing field of immuno-oncology.
The active ingredient pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is established in the treatment of 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 activate the body’s own cellular anti-tumor immune response and kill e.g. melanoma cells.
Since 2015, Keytruda has been established for the treatment of advanced melanoma, lung and other types of carcinoma. In 2021, the reference market for Keytruda was reported at a size of more than USD 17 billion worldwide.[i] Expert analyses predict that Keytruda will become 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]
The development and commercialization rights for FYB206 are fully owned by Formycon. Important IP has already been created and patent applications have been filed, with data from the development of alternative formulations. Following convincing results from the extensive analytical protein characterization as well as significant progress in the development of the manufacturing process, a comprehensive data package is currently being compiled in order to closely align further program steps in Scientific Advice Meetings with the EMA and FDA in the second half of the year. Adjusting the manufacturing process to commercial scale is planned for the end of 2022. For this purpose, Formycon has already secured GMP manufacturing capacities at a renowned contract manufacturer.
“Cancer, in its various forms, is still one of the most common and serious diseases of our time. The cost of effective cancer treatments has become a major challenge for healthcare systems around the globe. With the development of a Keytruda biosimilar, we are pursuing the goal of facilitating access to this important medication for patients worldwide, while at the same time providing urgently needed savings for the healthcare systems,” says Dr. Stefan Glombitza, CEO of Formycon AG.
Formycon’s CSO, Dr. Andreas Seidl, adds: “With FYB206, we have a promising biosimilar candidate in the fast-growing field of immuno-oncology in our development portfolio. Keytruda is a highly effective drug being successfully used as a breakthrough therapy for several types of cancer, including skin, lung and colorectal cancer.”
[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
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has six biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207.
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2025, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15B by 2020. By 2030, analysts estimate that this figure could rise to over $60B.