FDA Approves 19th Biosimilar, 2nd for Enbrel

Regulatory NewsRegulatory News
| 26 April 2019 | By Zachary Brennan 

Samsung Bioepis confirmed to Focus via email Friday that the company’s biosimilar to Amgen’s Enbrel (etanercept), to be known as Eticovo (etanercept-ykro), has been approved by the US Food and Drug Administration (FDA).

This is the second US approval of an Enbrel biosimilar, with the first coming in August 2016 for Sandoz’s Erelzi (etanercept-szzs), although Erelzi has yet to launch. In the EU, however, both Sandoz and Biogen/Samsung have successfully launched their Enbrel biosimilars (more on the sales below).

Meanwhile, Amgen and Sandoz are continuing to battle in court over when Erelzi can launch in the US, with analysts predicting anywhere from 2021 to 2029.

The prolonged periods between FDA approval and biosimilar launch is erasing the potential for large savings across the country.

Carol Lynch, president of Sandoz US, told the Center for Biosimilars recently: “We actually got approval for Erelzi in August of 2016 and yet we’re still not allowed to market this product because we’re in litigation and we can’t bring it to market until that court case has been resolved. At this rate, it looks like it will be around $3 billion of savings that have been missed, and for patients in the system and for the healthcare system as a whole, I think that’s something that we all need to take on.”

Meanwhile, Biogen, which partners with Samsung on biosimilars, recently said that its biosimilar revenues increased to $175 million in the first quarter of 2019, compared to $128 million in the first quarter of 2018. The increase was driven by the launch of Imraldi (adalimumab) in Europe and $124 million in sales of Benepali (etanercept) worldwide. Samsung did not respond to a request for comment on its planned launch of Eticovo.

According to Bernstein analyst Ronny Gal, the overall European market for etanercept includes: 55% market share for Amgen’s Enbrel, 38% for Samsung’s Benepali and 7% for Sandoz’s Erelzi. Benepali has made the most gains in the UK, where it controls 72% of the market, in Scandinavia, where it controls 53% of the market, and in Germany, where it’s won 45% of the market, the note from March said.


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