FDA OKs Sandoz’s Biosimilar to Enbrel

The US Food and Drug Administration (FDA) has approved Sandoz’s Erelzi (etanercept-szzs), a biosimilar of Enbrel (etanercept), for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA). Erelzi is the second biosimilar from Sandoz, a division of Novartis, approved in the US through the FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act. The first was Zarxio (filgrastim-sndz), based on the reference product, Neupogen, marketed by Amgen.

The FDA's approval of Erelzi is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Erelzi is biosimilar to Enbrel, according to the FDA. Erelziis is manufactured by Sandoz Inc., based in Princeton, New Jersey, at Novartis Pharma in Stein, Switzerland.

Sandoz currently markets three biosimilars.

Sandoz says it plans to launch five biosimilars of oncology and immunology biologics across key geographies by 2020. This will be enabled by 11 filings over a three-year period (2015-2017), with six already submitted.

Source: Novartis and US Food and Drug Administration

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