Celltrion announced on March 25 that it has received a recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for the full label of its Xolair (active ingredient: omalizumab) biosimilar “CT-P39.”
The original drug, Xolair, to which CT-P39 is a biosimilar, is a blockbuster antibody biopharmaceutical used for allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria, recording global sales of approximately 5 trillion won in 2023. Recently, it has also received approval for an additional indication for food allergies, which is expected to further increase the market size for this therapy.
CHMP, which recommended the marketing authorization, discusses the approval based on the scientific evaluation of the medicine and presents its opinion to the EMA. This recommendation by CHMP is known to play a crucial role in the final approval by the European Commission (EC), essentially meaning it signifies the approval of the drug in Europe.
Following CHMP’s recommendation for CT-P39, Celltrion expects to obtain final approval from the EC as early as May. If the authorization is indeed acquired at that time, CT-P39 will become the first biosimilar of Xolair to be approved in Europe, marking it as a “first mover” product. Celltrion plans to proceed with commercialization as soon as the approval is finalized, aiming for a swift market entry.