Samsung Bioepis files Humira biosimilar in EU

South Korea’s Samsung Bioepis has filed its biosimilar of AbbVie’s Humira (adalimumab) in Europe, a sign that the market for these cheaper near-copies of biological drugs is hotting up.

The European Medicines Agency has accepted the Samsung – Biogen joint venture’s SB5 for review, around eight months after Amgen filed ABP 501 its Humira biosimilar, in Europe.

Biosimilars firms such as Novartis’ Sandoz unit are also developing near-copies of Humira in a bid to steal sales from AbbVie.

Humira, indicated in a range of diseases including rheumatoid arthritis, is the world’s biggest selling drug, with sales expected to top $15 billion this year.

SB5 is Samsung Bioepis’ third anti-TNF-alpha biosimilar candidate filed in Europe, after Benepali, a biosimilar of Amgen/Pfizer’s Enbrel (etanercept) and Flixabi, a near-copy of Johnson & Johnson/MSD’s Remicade (infliximab).

In its pipeline, Samsung is developing biosimilars of several other of the world’s other big selling medicines, such as Sanofi’s Lantus (insulin glargine), Roche’s cancer drugs Herceptin (trastuzumab) and Avastin (bevacizumab).

Samsung Bioepis is competing with Celltrion, also from South Korea, which is developing a similar pipeline of biosimilars and was the first company to get a copy of Remicade approved in the US and EU – a landmark as this was the first biosimilar of a monoclonal antibody to make it to market.

IMS Health estimates that healthcare systems in Europe’s five largest markets and the US could save up to $110 billion by using biosimilars instead of more expensive originator drugs.

Amgen’s ABP 501 looks likely to get approved by the US Food and Drug Administration, after a non-binding recommendation from a panel of advisers last week.

But AbbVie has set up a web of patents to fend off competitors and it is unclear when Amgen will be able to launch its rival, even though the main patent on the drug runs out this year.

Celltrion’s Remicade near-copy  has also been approved in the US, but not launched, because of a similar set of defences set up by Johnson & Johnson, although it is now been on sale for more than a year in most of the large European markets.

Christopher Hansung Ko, president & CEO of Samsung Bioepis, said: “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.”