Celltrion launched Omlyclo, a treatment for chronic spontaneous urticaria and allergic asthma containing omalizumab, in the U.S. on Oct. 5, the company said Oct. 6.

Omlyclo is the first omalizumab biosimilar to enter the U.S. market. Celltrion aims to replicate in the world’s largest pharmaceutical market the rapid market penetration it achieved as a first mover in Europe.

In particular, Omlyclo was listed as a preferred drug on the commercial insurance formulary of Optum, one of the largest pharmacy benefit managers (PBMs) in the U.S., at the time of launch.

PBMs negotiate drug prices and rebates with pharmaceutical companies on behalf of insurers and manage formularies, which are lists of drugs covered by insurance. Whether a drug is included on a formulary and its placement priority can significantly affect patient access and a pharmaceutical company’s market share.

Omlyclo was launched in the U.S. at a wholesale acquisition cost (WAC) about 15% lower than that of the reference product. It is available in three dosage strengths — 75 mg, 150 mg and 300 mg — to address different dosing needs based on patients and treatment settings.

In March last year, Omlyclo received approval from the U.S. Food and Drug Administration for all indications held by the reference product in the U.S., including asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and IgE-mediated food allergy.

It also secured interchangeable status. When requirements under applicable state laws and insurance policies are met, the designation allows the product to be substituted for the reference product at the pharmacy level, which is expected to improve access for health care providers and patients and support broader prescribing.

In the U.S. biopharmaceutical market, inclusion on PBM formularies is considered a key factor determining insurance reimbursement and patient access. Celltrion’s U.S. subsidiary signed an agreement with Optum, one of the three largest PBMs in the U.S., to secure formulary placement for Omlyclo.

Under the agreement, Omlyclo was listed as a preferred drug on commercial insurance formularies administered by Optum. This secures channels through which the product can be sold, and Celltrion plans to step up local marketing targeting health care providers, insurers and distribution channels to expand actual prescribing.

Celltrion is also negotiating formulary placement with other major PBMs. Some negotiations are nearing completion, and additional placements are expected to further expand insurance coverage and patient access in the U.S.

Celltrion’s U.S. subsidiary plans to rapidly expand PBM formulary coverage while using prescribing data and preferences among health care providers and patients accumulated through the prescribing process to further refine its sales strategy by market.

Celltrion plans to replicate in the U.S. the growth formula it established in Europe: “early launch → securing market access → expanding prescriptions.” In the U.S., the company can immediately leverage its established direct sales network and existing sales and distribution infrastructure for its other products for Omlyclo.

Kim Bon-jung, CEO of Celltrion’s U.S. subsidiary, said, “Omlyclo combines the first-mover advantage of being the first omalizumab biosimilar in the U.S. with product competitiveness based on approval for all indications, interchangeable status and three dosage strengths. We will combine our first-mover growth experience proven in Europe with our direct sales network in the U.S. and quickly finalize additional PBM formulary placements to develop Omlyclo into a major growth product in the U.S.”

Celltrion launched Omlyclo, a treatment for chronic spontaneous urticaria and allergic ast …

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