On May 20, 2021 Tanvex BioPharma, Inc. issued a press release announcing that the FDA has not approved its 351(k) application for TX01, a biosimilar version of filgrastim.
In the announcement, Tanvex cited the FDA’s need to complete manufacturing site inspections, which have been altered by COVID-19 pandemic restrictions. It is unclear whether any additional information related to the product’s development is being requested by the FDA. Tanvex stated, “Based on the [complete response letter], Tanvex will continue to update FDA with supplemental information and the Company plans to work closely with FDA to get the application approved.”
Tanvex is seeking to launch the third filgrastim biosimilar on the market.
In other biosimilar news… On June 1,Biogen and Bio-Thera presented results from its phase 3 study of BAT1806, an investigational biosimilar referencing tocilizumab. The study tested the biosimilar against the reference product Actemra® (EU-licensed) in 621 patients with moderate-to-severe rheumatoid arthritis who had inadequate response to methotrexate therapy.
The partners announced that “the study met its primary endpoints, demonstrating equivalence to the reference medicine,” based on the primary endpoint of American College of Rheumatology 20% response (ACR20). If approved by the FDA, Biogen would market the agent throughout the world, excluding China and Taiwan. Globally, Roche earned roughly $340 million on Actemra in the first quarter of 2021 (or an estimated $1.4 billion extrapolated in annual sales) in the US, across indications.