Room for another: Sandoz files Humira biosimilar in US
Novartis subsidiary Sandoz announced today the US Food and Drug Administration (FDA) has accepted to review its proposed version of AbbVie’s bestselling biologic Humira (adalimumab) submitted through the dedicated 351 (k) biosimilar pathway.
If successful, it would be the third biosimilar approval for Sandoz following Zarxio (filgrastim-sndz) – a version of Amgen’s Neupogen approved in March 2015 – and its Enbrel biosimilar Erelzi (etanercept-szzs), approved in August 2016.
But it would also become the third Humira biosimilar approved, after Amgen’s Amjevita (adalimumab-atto) and Boehringer-Ingelheim’s Cyltezo (adalimumab-adbm) got the regulatory thumbs up in September 2016 and August 2017, respectively.
Due to patent issues, no adalimumab biosimilar is available in the US, and a long-standing legal battle between Amgen and AbbVie recently concluded with a January 2023 launch date for Amjevita. By then there could be many more adalimumab biosimilars approved and looking to access a market worth $10.4bn in 2016.
But Sandoz remains confident it will make an impact on the market: “Our experience and leadership in this filed has demonstrated that there is room in most markets for a number of competitors,” said spokesperson Chris Lewis.
“For instance, our Zarzio was the third biosimilar filgrastim to enter the European market, but overtook all biosimilar competitors and the manufacturer of the reference medicine within a few years.”
He added Sandoz is “the only company with five biosimilar medicines marketed in various countries worldwide,” and is supported by the Novartis Biologics Technical Development and Manufacturing (BTDM) organisation, which has 10 sites dedicated to developing and manufacturing biologics.
Lewis could not comment on regulatory timelines and a prospective adalimumab launch.
