Sandoz Enbrel biosim cruises at FDA panel, endangering key Amgen sales

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In the second straight resounding vote in favor of a biosimilar in as many days, Sandoz’s version of Amgen’s Enbrel earned unanimous support from an FDA panel Wednesday.

With the 20-0 vote, Novartis’ generics unit advances in its crusade toward a potential big sales boost and a second biosim on the U.S. market that’s just getting acquainted with the biosimilar concept. Dubbed GP2015, Sandoz’s Enbrel biosim looks “highly similar” to the original product, FDA staffers said earlier this week, and could now be in a position to take a big bite out of the California company’s $5.1 billion in sales from its anti-TNF blockbuster.

Prior to the meeting, FDA staffers said they considered there to be “sufficient scientific justification” in extrapolating psoriasis biosimiliarity data to other indications Sandoz is seeking in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis, they said. The committee agreed, recommending the biosim for all of Enbrel’s approved indications. The FDA doesn't always follow committee recommendations, but it typically does.

Wednesday’s meeting represented the second straight day an FDA expert committee unanimously supported a biosimilar following Tuesday’s vote in favor of Amgen’s copy of AbbVie rheumatoid arthritis megablockbuster Humira. This time, though, it’s Amgen fending off biosimilar competition while Sandoz inches forward in the field.

The Swiss pharma’s generics outfit is betting big in biosims, saying recently it’s shooting to market 5 by 2020 in the U.S. and other “key geographies.” It’s planning to submit 11 regulatory filings by the end of 2017 and expects to gain approval for copies of Enbrel, Humira, Neulasta from Amgen, Remicade from Johnson & Johnson and Merck, and Rituxan from Roche. The company is already blazing a path with the first U.S.-approved biosim in Zarxio, a copy of Amgen’s Neupogen.

- here's Sandoz's release

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