Alteogen said Wednesday that it has patented a formulation for ALT-LS2, a subcutaneous (SC) injectable formulation that incorporates human hyaluronidase technology into its Herceptin biosimilar (ALT-L2) for breast cancer therapy.
The company plans to file additional patent applications and Patent Cooperation Treaty applications in 12 countries, including the U.S. and Europe. As a result of the patent, the company expects it will be able to monopolize the market for the Herceptin subcutaneous injectable biosimilar market.
Herceptin is one of the most purchased biomedicine with an estimated 7.8 trillion won ($6.9 billion) in sales. It has applications for early and metastatic breast cancer and metastatic gastric cancer.
As the drug’s U.S. patent will expire in June, five companies -- Mylar and Biocon, Amgen and Allergan, Pfizer, Samsung Bioepis and Celltrion – are planning to launch an intravenous (IV) injection biosimilar version of the drug.
To reduce any fallback, Roche, the original developer of the drug, launched Herceptin Hylecta, which changed the medication from an IV to SC. The SC formulation has proved its marketability as it acquired more than 50 percent market share in the European market after its launch in 2013.
“With the launch of Herceptin biosimilars in the U.S this June, Roche has taken the lead in the biosimilars market by launching Herceptin Hylecta,” a company official said. “The hyaluronidase developed by Alteogen can be applied to Herceptin, a breast cancer treatment, to make the drug into an SC injection, while also allowing various other IV injected drugs to SC injected drugs.”
Such a wide range of use has piqued interest from various multinational companies regarding Alteogen’s patented technology, he added.