FDA Approves Third Biosimilar in US, First for Amgen's Blockbuster Enbrel

Regulatory NewsRegulatory News | 30 August 2016 |  By 

The US Food and Drug Administration (FDA) on Tuesday approved Sandoz’s biosimilar to Amgen’s blockbuster Enbrel, which will be known as Erelzi (etanercept-szzs) for all indications included in the reference product’s label.

Erelzi is the second biosimilar approved via the Biologics Price Competition and Innovation Act in the US from Sandoz (the first was for Zarxio (filgrastim-sndz), which is biosimilar to Amgen's Neupogen).

The approval of Erelzi follows a unanimous vote (20-0) by the FDA’s Arthritis Advisory Committee (AAC) in July to recommend use in all indications of the reference product.

Clinical studies that helped the approval of Erelzi included four comparative pharmacokinetic studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis. Extrapolation to all indications approved for use on the reference product label is on the basis that the Sandoz biosimilar and the Amgen reference product are essentially the same, Sandoz said.

In terms of the discount that Sandoz will provide on the biosimilar, Sandoz spokeswoman Elizabeth Renz told Focus: "It is too early to speculate about the price of Erelzi. That being said, we believe patients in the US can benefit greatly from a competitively priced etanercept manufactured in accordance with strict GMPs and high quality standards."

Amgen and Sandoz are still working on the details of when Erelzi will launch in court.

"Immunex/Amgen and Sandoz have entered into an agreement with respect to a preliminary injunction regarding Sandoz’s biosimilar etanercept as set out in the Court’s order of August 11, 2016. I cannot comment further," Renz said. Enbrel was first licensed in 1998, according to FDA.

An application for the biosimilar also has been accepted by the European Medicines Agency and is currently undergoing review. Sandoz also says it has plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020 via 11 regulatory filings over a three-year period (2015-2017), with six already submitted.

The good news for Sandoz (which comes as the company has been working for more than three years on its biosimilar application) follows a similarly positive report from FDA staff last month and a similarly positive result at the advisory committee for Amgen’s biosimilar for AbbVie’s blockbuster Humira (adalimumab).

To learn more about biosimilars, check out Focus' explainer here.


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