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First Merck/Samsung biosimilar cleared in South Korea

Approval of Brenzys further opens up competition in biosimilar market
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Merck & Co and Samsung Bioepis' partnership has borne its first fruit with approval in South Korea for Brenzys, their biosimilar version of Amgen's arthritis drug Enbrel.

Brenzys (etanercept) can now be used as an alternative to Enbrel for adults with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and psoriasis after the launch of the product in South Korea, which is scheduled for later in 2015 or early 2016.

Enbrel is a tumours necrosis factor (TNF) inhibitor and currently Amgen's second biggest-selling drug, bringing in $2.46bn in the first six months of this year, a rise of 10% on the first half of 2014.

The emergence of competition to the brand comes as Amgen is also facing biosimilar rivals for other top products, including its white blood cell stimulator Neupogen (filgrastim). Sandoz' copycat version of the drug - called Zarxio - has just been launched in the US.

Merck and Samsung hailed their first approval, saying it was the first stage in an initiative "to offer high-quality biosimilar alternatives to existing biologic medicines to help address patient and healthcare system needs worldwide."

Perhaps recognising that there is still some debate about how readily doctors and patients will embrace biosimilars, Merck said it will launch the new drug with "comprehensive education and support services" which will cover "biosimilar education, disease education, and reimbursement and access support."

Merck forged its biosimilar collaboration with Samsung in 2013, revealing that the two companies would be working on a number of biosimilar candidates.

Since then the companies disclosed they are developing a version of Sanofi's big-selling Lantus (insulin glargine) product, which is already facing its first direct competition from Eli Lilly/Boehringer Ingelheim.

Along with etanercept and insulin glargine, Merck and Samsung also have biosimilars of Johnson & Johnson's Remicade (infliximab) and AbbVie's Humira (adalimumab) - also TNF inhibitors - as well as Roche's breast cancer therapy Herceptin (trastuzumab) in late-stage clinical development.

"Additional regulatory filings for each of these five biosimilar candidates are expected to occur in the 2015-2016 timeframe," they said in a statement.

Samsung Bioepis is a joint venture between Samsung and Biogen, and is reported to be considering an initial public offering (IPO).

Article by
Phil Taylor

9th September 2015

From: Regulatory

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