Celltrion announced on Sep. 23 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave an opinion in favor of the sale of Remsima SC on Sept. 20. The company requested the EMA 10 months ago to approve sales of the world’s first subcutaneous infliximab biosimilar.
The CHMP is an organization providing the EMA with opinions on new drug approvals based on scientific evaluation. The CHMP’s approval recommendation is regarded as the EMA’s approval.
Celltrion, in the meantime, already completed patent application processes for the biosimilar in about 130 countries worldwide and Remsima SC is expected to dominate the global subcutaneous infliximab biosimilar market until 2038. The company is anticipating that Remsima SC will boost the global TNF-alpha inhibitor market, which is currently led by Humira, Enbrel and Remicade, from 45 trillion won to at least 55 trillion won.
Consumers of Remsima SC, which can be self-injected every two weeks, are expected to include those satisfied with the efficacy of infliximab yet wishing to use it in a more convenient way and Humira and Enbrel users who have developed a tolerance. Celltrion Healthcare, which markets and distributes Celltrion products abroad, is going to initiate the marketing of Remsima SC in Europe without delay once the EMA gives its final approval.
In the European pharmaceutical market, Celltrion’s autoimmune disease biosimilar Remsima, which was approved by the EMA in September 2013, posted a market share of 57 percent in the first quarter of this year. Likewise, its hematologic malignancy drug Truxima and breast and gastric cancer drug Herzuma have increased their market shares to 37 percent and 13 percent since approvals in February and November 2017, respectively.