# Celltrion biosimilar expansions in the United States

> Live situation record from CLSTR: https://clstr.news/situations/celltrion-biosimilar-expansions-in-the-united-states
> Updated: 2026-10-07T00:13:33.000Z. Sources: 5. Developments: 2.

Celltrion has expanded its presence in the United States market through the launch and regulatory approval of multiple biosimilar products.

In early October 2026, the company launched Omlyclo, the first omalizumab biosimilar in the U.S., intended for treating allergic asthma and chronic spontaneous urticaria. The drug was released with a wholesale acquisition cost approximately 15% lower than the original product and secured ‘preferred drug’ status on the Optum insurance formulary. Omlyclo has also obtained interchangeability status, allowing for pharmacy-level substitution.

Shortly thereafter, the FDA granted additional approval for Avtozma, a tocilizumab biosimilar, to treat COVID-19 in pediatric patients aged 2 and older. This expansion follows existing approvals for various inflammatory conditions. Avtozma is supplied at a wholesale price approximately 35% lower than the original drug, Actemra, and has secured placement on preferred drug lists with major pharmacy benefit managers including Express Scripts, CVS Caremark, and Optum.

## Timeline

### 2026-10-07: Celltrion's Avtozma receives FDA approval for pediatric COVID-19

Celltrion's tocilizumab biosimilar, Avtozma, has received FDA approval to treat COVID-19 in pediatric patients aged 2 and older, expanding its use beyond adult populations in the U.S. market.

3 sources. https://clstr.news/cluster/celltrions-avtozma-receives-fda-approval-for-pediatric-covid-19

### 2026-10-05: Celltrion launches Omlyclo, the first omalizumab biosimilar in the U.S

Celltrion launched Omlyclo, the first omalizumab biosimilar in the U.S., securing preferred status on Optum’s formulary to treat asthma and allergic conditions.

4 sources. https://clstr.news/cluster/celltrion-launches-omlyclo-the-first-omalizumab-biosimilar-in-the-us

---
Cite as: Celltrion biosimilar expansions in the United States. CLSTR, https://clstr.news/situations/celltrion-biosimilar-expansions-in-the-united-states
