EMA to review Samsung Bioepis' Humira biosim application

Incheon-based Samsung Bioepis received acceptance of a European Marketing Authorization application for a biosimilar of AbbVie's ($ABBV) blockbuster Humira (adalimumab), which earlier this year was the subject of a legal tussle between the two firms.

The application for SB5 by Samsung Bioepis--a joint venture between majority partner South Korea's Samsung Biologics and Biogen ($BIIB)--marks the third anti-TNF-α biosimilar candidate submitted for EMA review, the company said in a release.

It noted two biosimilars, Benepali (etanercept), and Flixabi (infliximab), subsequently received nods from the European Commission this year.

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“If approved, SB5 will join Benepali and Flixabi in Europe, which have already started to increase patient access to high-quality treatment options while driving down healthcare spending,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis.

“We will continue to work hard to advance one of the industry's largest biosimilar pipelines, so that more patients can access affordable medicines without any compromise in the quality of treatment,” Ko said.

An approval for an adalimumab biosimilar would come on the heels of a U.S. FDA nod this month for Amgen's ABP 501, presenting AbbVie with a two-front challenge. It has previously vowed to seek legal options to stem on the patent expiry dates for Humira across jurisdictions.

On the April 28 first quarter earnings call, AbbVie CFO Bill Chase said that international sales for Humira (adalimumab) rose 4.6% to nearly $1.4 billion on a currency adjusted basis, and along with chairman and CEO Rick Gonzalez, reasserted that biosimilar challenges to the franchise will be vigorously contested.

The company has been steadfast that a series of patents covering Humira will extend its status 6 more years beyond the end of 2016 in the U.S. against a biosimilar. Its exclusivity is set to expire in the European Union in April 2018.

But Samsung Bioepis earlier this year asked the U.K. High Court of Justice to nullify dozens of additional patents on Humira in a case that continues. If approved, any sales of the Humira biosimilar in Europe would be handled by Biogen.

The application, the company said, was based on a yearlong Phase III study which randomized 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy.

The Humira biosimilar is one of 6 biosimilar candidates either approved in regulated markets for Samsung Bioepis or in development that include versions of Sanofi's ($SNY) blockbuster insulin Lantus (insulin glargine), Roche's ($RHHBY) breast cancer drug Herceptin (trastuzumab) and multicancer drug Avastin (bevacizumab)--with another 7 molecules at early stages.

Reports and company statements suggest an initial public offering for the firm in the coming year is possible with estimates of raising more than $1 billion.

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