Apotex Applies for Biosimilar, Bringing U.S. Total to Five

The FDA has accepted Apotex’s BLA for a biosimilar of Amgen’s blockbuster chemotherapy product Neupogen, the Canadian generics maker said, making it the fifth publicly disclosed biosimilar application in the U.S.

Apotex’s announcement marks two important milestones in the development of biosimilars. The proposed therapy, which Apotex wants to market under the brand name Grastofil, represents the first time that the same reference biologic has faced a second biosimilar application. Neupogen (filgrastim) was the first biologic to face a publicly disclosed biosimilar application, from German drugmaker Sandoz under the proposed brand name of Zarxio. That filing was disclosed last summer.

This also is the first time that a single manufacturer has acknowledged filing two biosimilar applications with the FDA. Apotex joined the would-be U.S. biosimilar field late last year with an accepted bid against Amgen’s Neulasta (pegfilgrastim), a longer-lasting version of Neupogen. Apotex is developing both therapies jointly with Intas Pharmaceuticals.

Along with Sandoz, the other publicly disclosed biosimilar applications come from South Korea-based Celltrion against Janssen’s Remicade (infliximab); and Hospira against Amgen and Janssen’s Retacrit/Procit (epoetin alfa).

None of these has been approved in the U.S. since Congress created a pathway for the therapies as part of the 2010 Affordable Care Act. The FDA accepted Appotex’s filgrastim application Feb. 13, which could make for agency action by mid-December based on biosimilar review goals.

The next regulatory hurdle for U.S. biosimilars is an FDA advisory committee meeting in March to look at Celltrion’s application. A separate committee voted unanimously in January to recommend approving Sandoz’s Neupogen biosimilars.

The FDA has said it plans to hold advisory committee meetings for every biosimilar application for the foreseeable future, although that may change as the agency develops its approval pathway. The agency anticipates five biosimilar applications a year and has committed to acting on 80 percent of submissions within 10 months of receipt.

While Sandoz’s version breezed through the advisory panel with relative ease, Apotex is not assured the same reception. Sandoz’s biosimilar has been marketed for years in Europe, where millions of days of exposure across hundreds of thousands of patients helped to ease FDA advisory committee members’ concerns about differing pharmacodynamics parameters in the submission.

Apotex said that it currently markets Grastofil in Germany and Slovakia, where the therapy is distributed by the firm’s marketing partner, Stada. — Bryan Koenig