Celltrion applies to EU for approval for cancer biosimilar
Celltrion applied to the European Medicines Agency (EMA) for approval for CT-P16, its biosimilar version of anticancer drug Avastin.
The drug is an identical copy of bevacizumab, better known by the name it is marketed under by Switzerland’s Roche, Avastin. It is used to treat metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer and glioblastoma.
Biosimilars, according to the U.S. Food and Drug Administration (FDA), are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less.
The Avastin patent expired in July 2019 in the United States and will expire in January 2022 for most parts of Europe. The size of the global bevacizumab market was about 7.7 trillion won ($6.4 billion) in 2020, and around 2.2 trillion won in European countries.
Celltrion has been waiting for approvals from Korea's Ministry of Food and Drug Safety and the U.S. FDA. The company aims to release the product in the second half of next year.
If approved, it will be Celltrion’s third anticancer biosimilar after Truxima for blood cancer and Herzuma, which targets stomach and breast cancers. The European market share for Truxima came to 38.3 percent in the first quarter of the year, and 14.8 percent for Herzuma, according to Celltrion. Herzuma has the largest market share in Europe among all biosimilars referencing Roche’s Herceptin.
“Celltrion is set to expand its anticancer biosimilar business portfolio as it started the approval process not only in Korea and the United States, but also in European countries,” said a spokesperson for Celltrion.
Celltrion is in Phase 3 clinical trials for various dugs including CT-P39, a biosimilar referencing allergic asthma treatment Xolair, CT-P41, a drug referencing osteoporosis treatment Prolia, and CT-P42, a drug referencing eye treatment Eylea. Celltrion aims to gain approval for at least one biosimilar annually through 2030.
BY SARAH CHEA [firstname.lastname@example.org]