On October 1, Tanvex BioPharma, Inc. (formerly La Jolla Biologics) announced that it has filed its 351(k) application with the US Food and Drug Administration (FDA) for its figrastim biosimilar. If approved, Tanvex’s product, TX-01, could join two approved and marketed agents (Sandoz’s Zarxio® and Pfizer’s Nivestym®). Two other agents (by Adello and Apotex, respectively) are still in the approval process, although an FDA decision on Adello’s biosimilar is overdue (filing was in September 2017).
Tanvex has been flying under the radar, and is unfamiliar to most industry watchers. This company, which is investigating three other biosimilar agents, will be featured in a future post.