Celltrion (068270.KS) has launched Omlyclo, its omalizumab biosimilar, in the United States. It is the first omalizumab biosimilar to reach the U.S. market.
Celltrion said on the 6th that it launched Omlyclo in the U.S. on the 5th. Omlyclo is a biosimilar to Xolair, the original drug whose active ingredient is omalizumab. It has been approved for all indications the original drug holds in the U.S., including asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps and IgE-mediated food allergy.
The drug launched at a wholesale acquisition cost about 15% below that of the original product. It comes in three dosage strengths — 75 milligrams, 150 milligrams and 300 milligrams — and has secured interchangeability status among biosimilars in the U.S. That designation allows pharmacists to substitute it for the original drug when state laws and insurance requirements are met.
A notable aspect of the market entry is the company's early foothold on pharmacy benefit manager formularies. Celltrion's U.S. unit signed a contract with Optum, one of the three largest PBMs in the U.S., listing Omlyclo as a preferred drug on private insurance formularies. Because PBMs manage drug prices and prescribing conditions covered by insurers, formulary listing is considered a critical gateway for biosimilars to translate into actual prescriptions in the U.S.
Celltrion is negotiating formulary listings with other major PBMs, and some of those talks are nearing contract signings, according to the company. Additional listings could widen Omlyclo's insurance coverage and patient access.
The company's earlier entry into Europe is also seen as a foundation for its U.S. push. Omlyclo is currently sold in 26 European countries, and in Spain its share of the omalizumab market topped 90% as of July this year. In Denmark, Celltrion expects to reach a share of about 98% by the end of the year on the back of a national tender win.
Celltrion plans to expand prescriptions of Omlyclo by drawing on its market entry experience in Europe and its direct sales network in the U.S. Another strength, the company said, is its ability to tap the sales and distribution network built through existing biosimilars such as Truxima and Inflectra.
Its existing products have also held onto U.S. market share. According to Celltrion, Truxima led the market for a sixth consecutive month in August with a 39% share. Inflectra held 31%, while Steqeyma and Yuflyma held 15% and 12%, respectively.
"Beyond the first-mover advantage of being the first omalizumab biosimilar in the U.S., Omlyclo has competitive strengths in covering all indications, securing interchangeability and offering three dosage strengths," said Kim Bon-joong, CEO of Celltrion USA. "We will quickly wrap up additional PBM listings and grow Omlyclo into a major growth product in the U.S."
