The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee has recommended approval of Celltrion‘s Rituxan biosimilar CT-P10.

CT-P10 is a proposed monoclonal antibody (mAb) biosimilar to Biogen and Genentech USA’s Rituxan (rituximab).

Celltrion and its biosimilar marketing partner Teva sought approval as a single agent and combination therapy for three types of B-cell Non-Hodgkin’s Lymphoma (NHL).

The Oncologic Drugs Advisory Committee recommended the approval based on a review of a comprehensive data package inclusive of foundational analytical biosimilarity data, nonclinical data, clinical pharmacology, immunogenicity, as well as clinical efficacy and safety data.

The FDA panel recommended the approval saying they found ‘no clinically meaningful differences between CT-P10 and Rituxan in terms of the safety, purity and potency of the product for the three proposed indications’.

“If approved by the FDA, CT-P10, a proposed biosimilar to Rituxan, will be the first rituximab biosimilar to be approved in the US for the three proposed indications.”

Though the panel’s recommendations are not binding, the federal agency usually follows them.

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Celltrion chief executive officer Woosung Kee said: “If approved by the FDA, CT-P10, a proposed biosimilar to Rituxan, will be the first rituximab biosimilar to be approved in the US for the three proposed indications.

“The development of biosimilars is of great importance in the field of oncology, and has the potential to increase accessibility to therapies for patients.”

Currently approved in 47 countries across the world, CT-P10 is the first mAb biosimilar approved by the European Commission (EC) for the treatment of oncology.

In October 2016, Celltrion and Teva Pharmaceutical Industries entered into an exclusive collaboration to commercialise the use of CT-P10 in the US and Canada.