FDA approves a third biosimilar, with the largest market

The FDA has approved its third biosimilar--this time it’s for the autoimmune treatment Enbrel, which had $9.5 billion in global sales last year. That makes this the largest marketed drug targeted to date by an FDA-approved biosimilar. Enbrel, which is sold by Amgen ($AMGN), was the fourth-largest drug by worldwide sales last year.

But the Enbrel biosimilar, known as Erelzi (etanercept-szzs)--as well as a Remicade biosimilar, Inflectra (infliximab-dyyb) from Pfizer ($PFE) and Celltrion that was approved earlier this year are being held up by patent disputes. So, an approval for these blockbuster biosimilars doesn’t mean they will be on the market anytime soon.

Enbrel is still a growth driver for Amgen; in fact, sales were up 10% year-over-year during the second quarter due to a combination of an increased net sales price and an improved competitive position.


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The drug sold about $5.1 billion in the U.S. last year. It is Amgen’s top-selling drug. The newly approved biosimilar version is from Novartis’ Sandoz division; it’s also targeting Amgen’s second-largest drug by sales, Neulasta. But the FDA issued a complete response letter for that biosimilar candidate last quarter.

Sandoz has already launched Zarxio, a biosimilar of Amgen's Neupogen. This was the first biosimilar approved last year in the U.S.--and the only, thus far, to be marketed in the country. Neupogen sales declined by almost one-quarter during the first half of the year compared with the same period a year prior to $256 million.

The unit is aiming for one of the broadest biosimilars portfolios in the industry; it’s planning three more FDA submissions for biosimilars this year and next for Amgen’s Epogen (epoetin alfa), AbbVie’s Humira (adalimumab) and Roche’s Rituxan (rituximab).

If Sandoz is successful, that could put it in line to have biosimilars for four out of 8 of Amgen’s top-selling drugs. The company is aiming “to deliver one of the broadest biosimilars portfolios in the industry,” its global head of drug development and CMO Vasant Narasimhan said on the company's most recent earnings call.

As for Amgen, it’s not just relying on lawyers to defend its sales. It’s pursuing its own biosimilar strategy. It recently had a positive panel for a biosimilar version of Humira--but AbbVie is making its own patent case in court to defend it.

In addition, Amgen has made regulatory submissions for a biosimilar version of two major Roche products: Avastin (bevacizumab) and Herceptin (trastuzumab).

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