Celltrion said Monday it has received a recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to grant the marketing authorization for the full-label application of CT-P39, a biosimilar to Xolair (omalizumab).
CT-P39's original drug, Xolair, is a blockbuster antibody biologic used for allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria. Last year, the drug had global sales of about 5 trillion won ($3.7 billion). Recently, the drug won the nod for a food allergy indication, raising expectations about even further growth of its market.
The CHMP, which recommended the approval, is a panel that discusses whether a medicinal product should be authorized based on the results of scientific evaluation and presents its opinion to the EMA. According to Celltrion, the CHMP's recommendation is known to be decisive for final approval by the European Commission (EC) and is regarded as de facto European approval of a drug.
With the CHMP's recommendation, Celltrion expects final approval from the EC as early as May. If so, CT-P39 will be the first biosimilar of Xolair to be approved in Europe and become a "first mover" product.
Celltrion added that upon receipt of the approval, It plans to commercialize the product as soon as possible to enable rapid market entry.
On March 11, Celltrion also completed its FDA submission for CT-P39 in the U.S., another major global pharmaceutical market. This further widens the gap between the company and its competitors in the race to enter the global omalizumab market.
"Once CT-P39 is approved in Europe, we expect to be the first mover in the market, which will allow us to expand our share based on that advantage rapidly," a Celltrion official said. "Aside from CT-P39, multiple global approvals and launches are planned this year, and we plan to accelerate our global market dominance and revenue expansion based on such launches."
Celltrion added that it would focus on product development and investment to expand its biosimilar portfolio to 11 products by 2025, in addition to the six already commercialized products. By 2030, the company plans to secure 22 products and achieve its goal of reaching 12 trillion won in annual sales.
Source:- Korea Biomedical Review