The regulator’s Oncologic Drugs Advisory Committee voted unanimously recommending approval of CT-P10, a proposed monoclonal antibody (mAb) biosimilar to Rituxan, to treat adult patients in three proposed indications.
Celltrion CEO Woosung Kee said: “We welcome the Oncologic Drugs Advisory Committee’s recommendation. If approved by the FDA, CT-P10, a proposed biosimilar to Rituxan, will be the first rituximab biosimilar to be approved in the United States for the three proposed indications.”
The first indication is relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma (NHL) as a single agent,
The second indication is previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
Final and third indication is non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.
The FDA will consider committee’s recommendation before taking action on the biologics license application (BLA) for the proposed Rituxan biosimilar.
The committee supported the Rituxan biosimilar after reviewing comprehensive data package, including foundational analytical biosimilarity data, nonclinical data, clinical pharmacology, immunogenicity and clinical efficacy and safety data.
In October 2016, Celltrion entered into an exclusive partnership with Teva to commercialize CT-P10 in the US and Canada.
Celltrion’s CT-P10 is a proposed biosimilar to Biogen and Genentech USA Rituxan, and is currently secured approval in 47 countries across the world.
CT-P10 is claimed to be the world’s first monoclonal antibody (mAb) biosimilar secured approval from the European Commission (EC) to treat oncology. It was first commercialized in Europe in 2017.
The active substance in CT-P10 will bind specifically to the transmembrane protein CD20 located on both malignant and normal B cells.
Teva North America commercial head and executive vice president Brendan O’Grady said: “If approved, Teva is well positioned to successfully commercialize CT-P10, given our unique portfolio of branded and generic medications, as well as patient support experience.”