Samsung Bioepis seeks EMA's okay for biosim

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Samsung Bioepis seeks EMA's okay for biosim

Samsung Bioepis announced Monday that it is seeking approval from the European Medicines Agency (EMA) to sell SB5, its biosimilar of the top-selling immune disease treatment Humira, in Europe.

Humira, the trade name for adalimumab, is a prescription treatment for ailments like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn’s disease, among others.

The drug is a type of TNF blocker, which suppress the immune system by blocking the activity of tumor necrosis factors, a substance that can cause inflammation and lead to diseases of the immune system.

Developed by AbbVie, an Illinois-based pharmaceutical company, Humira posted 16 trillion won ($12 billion) in revenue last year, making it the worldwide best-seller among the top three TNF inhibitors, also known as anti-inflammatory therapies.

Samsung’s SB5, a lower-cost version of Humira, is expected to snatch a portion of the pie should the European regulator green-light its sale.

“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 health care spending,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis.

He was referring to Samsung’s versions of two other best-selling anti-inflammatory therapies, Amgen’s Enbrel and Johnson & Johnson’s Remicade, for which the company received approval from the European Commission in January and May this year, respectively.

Each medicine utilizes different mechanisms even though they produce similar results.

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

Samsung is bracing to enter the United States with SB5, as the U.S. Food and Drug Administration (FDA) accepted its application in late May to consider approving sales.

The FDA is slated to make its decision on SB5, Benepali and Flixabi by the end of the year.

There are about 60 low-cost alternatives for top drugs in clinical trials currently seeking approval in the United States or Europe, the world’s two biggest pharmaceutical markets, according to Sanford C. Bernstein & Company.

These include 13 versions of Humira, of which Samsung’s SB5 is one.

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