In order to sell FYB206, a biosimilar of Merck’s popular cancer medication Keytruda (pembrolizumab), in the US and Canada, Zydus Lifesciences announced on Tuesday that it has signed an exclusive license and supply deal with Germany’s Formycon AG.
The action is noteworthy because the US patent for Keytruda, one of the best-selling immunotherapies in the world with yearly sales of over $20 billion, is set to expire in 2028. This might lead to competition from biosimilars in a market dominated by expensive cancer medications.
A biological medication that is very close to an already-approved, original biologic treatment but not exactly the same, with no clinically significant variations in safety or efficacy, is known as a biosimilar. The cost of biosimilars is lower.
Formycon will develop, register, produce, and deliver FYB206 under the terms of the December 9 contract, while Zydus will manage North American commercialization. It is anticipated that Zydus would file a Biologics License Application (BLA) with the USFDA shortly, indicating its intention to join the lucrative immuno-oncology market with an affordable substitute.
According to Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences, “this collaboration marks Zydus’ foray into the North American biosimilar market, starting with an immunotherapy medication.”
We hope to achieve substantial organizational growth and provide patients with the most value possible by increasing access to reasonably priced cancer care by pooling our resources and skills.
The collaboration highlights Formycon’s increasing influence in regulated markets.
According to Dr. Stefan Glombitza, CEO of Formycon, “FYB206 illustrates Formycon’s significant competence in creating biosimilar medicines for highly regulated nations.” “We are able to provide patients with this significant treatment alternative because to our partnership with Zydus.”
Keytruda is authorized for a number of conditions, such as head and neck malignancies, lung cancer, and melanoma. Biosimilars have a multibillion-dollar potential when its US patents begin to expire in 2028. As international players scramble to submit applications before the patent cliff, analysts anticipate fierce competition.
This transaction supports Zydus’s plan to expand its biologics footprint by purchasing Agenus Inc.’s California production facilities. Additionally, it puts the business in a position to take advantage of the $250 billion global biologics industry, where payer demand for reasonably priced choices and cost constraints are driving the adoption of biosimilars.
