Celltrion launches omalizumab biosimilar ‘Omriclo’ in the U.S.

(Seoul = Yonhap News) Reporter Park Sang-hyun = Celltrion [068270] announced on the 6th that it has launched 'Omriclo' (ingredient name: omalizumab), a treatment for chronic spontaneous urticaria and allergic asthma, in the United States.

Omriclo is the first omalizumab biosimilar to enter the U.S. market, and Celltrion reported that its wholesale price is about 15% lower than that of the original product.

There are three released doses: 75 mg, 150 mg, and 300 mg.

Omriclo received product approval from the U.S. Food and Drug Administration (FDA) in March last year.

The target indications include asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria, which are the same as the original drug.

Celltrion explained that Omriclo has achieved interchangeability status and can be replaced with the original product if it meets requirements such as relevant regulations and insurance policies.

To ensure Omriclo's early entry into the U.S. market, the company listed this product as a preferred drug in the private insurance formulary of Optum, a large prescription drug benefit management (PBM) company.

A Celltrion official said, "We are also negotiating registration with other large PBMs in the U.S.," and added, "We will begin full-fledged marketing targeting medical staff, insurance companies, and distribution channels to expand prescriptions for Omriclo."

He added, “We will continue the rapid market penetration achieved in Europe in the United States as well.”

Omriclo surpassed 90% market share in Spain in July of this year, and is known to have achieved sales performance that exceeded the original target in Italy as well.

Meanwhile, Celltrion's other products are also continuing to sell well in the United States.

The blood cancer treatment drug 'Truxima' (ingredient name: rituximab) recorded a 39% market share of related products in August and ranked first for six consecutive months.

The autoimmune disease treatment drug ‘Inflectra’ (ingredient name: infliximab) also maintains a leading market share. Inflectra is the American product name for ‘Remsima’.