Korea Business News Agency - NSP NEWS AGENCY.

(Seoul=NSP NEWS AGENCY) = On 21 March, OMLYCLO received a ‘full marketing authorization’ from the European Commission(EC), almost two months after receiving a ‘recommendation for approval’ opinion from the Committee for Medicinal Products for Human Use(CHMP) of the European Medicines Agency(EMA).

As a result, OMLYCLO became the first XOLAIR biosimilar product to receive formal product approval in Europe, gaining an upper hand in the market.

OMLYCLO’s original drug, XOLAIR, is an antibody biopharmaceutical used for allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria, and recorded global sales of approximately 5 trillion won as of 2023.

With the approval of OMLYCLO in Europe, Celltrion expects to secure stronger competitiveness in major global markets by expanding its product portfolio to a variety of diseases, including autoimmune disease treatments and anticancer drugs, as well as allergic disease treatments, which were previously released.

By Soon-ki Lee(s8789@nspna.com) and Bok-hyun Lee(bhlee2016@nspna.com)

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