First omalizumab biosimilar to enter US market with full indications and interchangeability status

Listed as preferred drug on Optum‘s commercial formulary at 15% discount to originator’s WAC

European market share tops 90% in Spain; Celltrion eyes early US foothold through direct sales network

Omlyclo (omalizumab), a biosimilar developed by Celltrion. [Celltrion]
Omlyclo (omalizumab), a biosimilar developed by Celltrion. [Celltrion]

Celltrion has launched Omlyclo, its biosimilar treatment for chronic spontaneous urticaria and allergic asthma, in the United States, completing its listing on the formulary of a major US pharmacy benefit manager.

Celltrion said Tuesday it launched Omlyclo — the first omalizumab biosimilar in the United States — on Monday (local time).

Omlyclo is priced at a wholesale acquisition cost approximately 15 percent below that of the originator product. It is available in three dosage forms — 75 mg, 150 mg and 300 mg — to accommodate varying patient administration needs.

The US Food and Drug Administration approved Omlyclo in March last year for all indications held by the originator product, including asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and IgE-mediated food allergy. The product also carries interchangeability status, allowing pharmacists to substitute it for the originator drug at the pharmacy level without a new prescription.

At launch, Omlyclo was listed as a preferred drug on the commercial formulary of a major pharmacy benefit manager (PBM) in the United States. Formulary inclusion by a PBM is a critical gateway that determines biopharmaceutical distribution and reimbursement in the US market. Celltrion said it is currently in negotiations with other major PBMs for additional listings, with some in the final stages of contract signing.

The company‘s strategy combines its first-mover track record in Europe with its US direct sales network. Omlyclo is currently sold in 26 European countries and, according to IQVIA data, surpassed a 90 percent market share in Spain in July. In Denmark, the company expects to reach a market share of around 98 percent by year-end through a national tender award.

Synergies with Celltrion‘s existing US direct-sales portfolio are also anticipated. As of August, its products held the following US market shares: Truxima for blood cancer (39 percent), Inflectra for autoimmune diseases (31 percent), Steqeyma (15 percent) and Yuflyma (12 percent).

The Omlyclo launch extends Celltrion‘s US direct-sales portfolio — previously concentrated in autoimmune and oncology treatments — into the allergy space, drawing on its first-mover status as the only omalizumab biosimilar in the US market, its interchangeability designation and its early entry onto a major PBM formulary.

“On top of the first-mover advantage as the only omalizumab biosimilar in the United States, Omlyclo has strong product competitiveness — full indications, interchangeability status and three dosage forms,” said Kim Bon-joong, CEO of Celltrion USA. “We will combine our first-mover growth experience proven in Europe with our US direct sales network, and swiftly complete additional PBM listings to establish Omlyclo as a key growth product in the US market.”


silverpaper@heraldcorp.com