Celltrion Healthcare said Thursday that Remsima, a biosimilar of Remicade that is an autoimmune disorder treatment, has become the first Korean medicine to surpass 1 trillion won ($885 million) in annual prescription amount.
According to IQVIA, a drug market research company, doctors have prescribed more than 1.3 trillion won worth of Remsima worldwide over the past year.
That gave the drug two titles -- the first antibody biosimilar in Europe to exceed the market share of an original drug, and the first drug in Korea to exceed an annual sale of 1 trillion won in the global market.
Remsima has also recorded cumulative prescriptions of about 2.6 trillion won in the global market as of the second quarter of this year. If the current trend continues, it will exceed 3 trillion won by the end of the year.
Despite its current success, the biosimilar struggled in the early stages of the business. In the absence of the concept of biosimilars, there was concern about the efficacy and safety of Remsima as a medicinal product.
“After the biosimilar was first launched in Europe in the second half of 2013, its annual prescription amounted to only 16.6 billion won the following year, taking a market share of only 1 percent,” a company official said. “However, Remsima has become increasingly trusted by local healthcare practitioners, with clinical data proven to be comparable to the original drug, which was supported by price competitiveness and a tailor-made sales strategy for global partners.”
As a result, the drug received approval from the U.S. Food and Drug Administration in 2016 and entered the U.S. market. By the end of last year, it was the first antibody biosimilar to exceed the market share of original drugs in Europe.
“Remsima's success continues to its successor products Truxima (ingredient: rituximab) and Herzuma (ingredient: trastuzumab),” the company official said. “Truxima is expanding its market faster than Remsima by achieving a cumulative prescription of about 300 billion won a year in the second quarter of 2017.”
Herzuma has also succeeded in winning bids from major European countries such as France, is also rapidly expanding its market with the interest of local healthcare professionals.
The company expects to receive sales approval for Herzuma and Truxima in the U.S. by the end of this year.
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