Japan approves a 3-week version of HerzumaCelltrion Healthcare has gained approval to sell the three-week version of Herzuma in Japan.
The Kosdaq-listed Celltrion subsidiary announced in a statement Thursday that Japan’s Ministry of Health, Labor and Welfare issued the approval Wednesday for the sale of the biosimilar.
Herzuma is a treatment for early-stage breast cancer, metastatic breast cancer and metastatic gastric cancer and is based on the blockbuster pill Herceptin, also known as Trastuzumab, developed by Roche.
Biosimilars are biological products that are approved based on proof that they are highly similar to other approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product but cost less.
Celltrion Healthcare won approval from the Japanese authority for the one-week Herzuma therapy in November last year, which requires 52 injections per year. The three-week therapy approved Wednesday is used by more than 90 percent of patients prescribed Trastuzumab.
The company said the latest approval will help Celltrion expand its reach in the Japanese pharmaceutical market by gaining access to more patients. According to pharmaceutical market tracker IQVIA, the current market for Trastuzumab in Japan is 400 billion won ($330 million).
“Interest in biosimilars that could lift the financial burden on government is continuously expanding as Japan faces aging population,” said a Celltrion Healthcare spokesperson in a statement.
“We will do our best to expand the prescription of Herzuma as we already have expanded our communications with Japanese medical institutions since co-promotion to strengthen the marketing activities on Herzuma.”
Celltrion Healthcare has been working with Tokyo-based distributor Nippon Kayaku to co-promote Herzuma in Japan. The two companies have been using distribution channels created together to reach a diverse range of consumers.
The breast cancer biosimilar has been selling well in the European market, as Herzuma’s market share rose to 13 percent in the first quarter compared to 10 percent a quarter earlier.
Celltrion has also established a joint venture named Vcell Healthcare in Shanghai with Nan Fung Group, a Hong Kong diversified conglomerate, to develop, manufacture and commercialize Herzuma and two other biosimilars in China.
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