FDA staffers like Sandoz' biosimilarity data for copy of Amgen's Enbrel


Amgen ($AMGN) is spending Tuesday making its case for a biosimilar approval before an FDA advisory committee. But come Wednesday, it’ll be Novartis’ ($NVS) Sandoz doing the same with a copy of an Amgen product--and so far, FDA staffers appear in favor.

Based on their review of plaque psoriasis data, Sandoz’ GP2015--a biosimilar of the California biotech’s anti-TNF blockbuster Enbrel--looks “highly similar” to the original, they wrote in briefing documents released Monday. And they also see “sufficient scientific justification” for extrapolating the psoriasis biosimilarity data to the other indications Sandoz is seeking in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis, they said.

That’s good news for Sandoz as it heads into Wednesday's advisory committee meeting; the generics giant wants to take the biggest bite possible out of the $5.10 billion in U.S. sales that Enbrel collected last year. The company already has one biosimilar on the market--Zarxio, a knockoff of Amgen’s Neupogen--that won the FDA’s green light in all of its reference product’s indications.

Sandoz isn’t the only player poised to score as the FDA ushers in the biosimliar age, though. Amgen itself is working to snag its own favorable panel vote for ABP 501, a biosimilar of AbbVie ($ABBV) anti-inflammatory behemoth Humira. It’s hoping to grab a piece Humira’s world-leading top-line haul, which could help it offset its own losses if Sandoz gets its product past regulators.

But Amgen isn’t putting all its eggs in the biosimilars basket as its top sellers age. It’s also rumored to be in the hunt for Medivation ($MDVN), a cancer drugmaker that’s captured the interest of Sanofi ($SNY)--and reportedly has Pfizer ($PFE), AstraZeneca ($AZN) and others weighing a potential move, too.

- see the FDA briefing documents (PDF)

Special Report: Top 20 generics companies by 2014 revenue - Novartis - Sandoz

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