Biogen gets European OK for rheumatoid arthritis drug

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Outside Biogen’s Cambridge headquarters.Uncredited

Biogen Inc. has grabbed a foothold in the growing European market for generic versions of biotech drugs, a step the Cambridge drug maker hopes will give it an advantage once the nascent US market for such biotech generics expands.

Biogen and its Korean partner, Samsung Group, said over the weekend that they won European Commission approval for their generic, or biosimilar, version of the rheumatoid arthritis drug Benepali. The drug is a near-replica of the branded drug Enbrel, manufactured by biotech giant Amgen Inc.

The same biosimilar made by Samsung Bioepis Co., a joint venture of Samsung and Biogen, was approved in South Korea last month. The European approval, allowing Biogen to market the drug in 28 countries, marks its first major entree into what could become a multibillion-dollar business in the coming decades: making near-copies of protein-based biologic drugs.

"This is a pretty significant commitment by the company," said Alpna Seth, the Swiss-based senior vice president and global head of Biogen's biosimilar business. "We believe Europe is the right time, right place for biosimilars. The US is still trying to figure this market out."

Like generic versions of pills, biosimilars are expected to lower the prices of what are some of the most expensive therapies, which can cost as much as hundreds of thousands of dollars per patient each year. Unlike generic pills, which are chemical copies, biosimilars are close cousins of cell-based biotech drugs, but not exact replicas.

European regulators began approving biosimilars in 2006, and about 20 are now being sold throughout the European Union. IMS Health, a market research firm in Danbury, Conn., has estimated biosimilars have brought median price reductions of about 35 percent in Europe, where drug prices are set separately in each country and are typically not disclosed.

Biogen has not said how much it will charge for Benepali in Europe.

In the United States, drug makers and consumer advocates have long haggled over how many years branded drugs can enjoy patent protection and have markets to themselves.

Just one biosimilar is on the US market: Zarxio, approved by the Food and Drug Administration last March as a version of Amgen's Neupogen, which prevents infections in cancer patients receiving chemotherapy. The generic drug maker Sandoz launched Zarxio at a 15 percent discount to Neupogen. Neupgen's price varies, based on the dosage and how long it's taken.

Sandoz is a division of Novartis AG of Switzerland, which has its global research and development unit, Novartis Institutes for BioMedical Research, headquartered in Cambridge.

Other companies working in the biosimilars field include Momenta Pharmaceuticals Inc. of Cambridge and Amgen, the California biotech that, like Biogen, wants to make both branded drugs and biosimilars.

Companies with experience in biotech manufacturing -- growing drugs from living cells -- will have the edge in biosimilars, said a Lexington health care industry consultant, Harry Glorikian. He said producing biosimilars is far more complex than making generic copies of pills.

Because of that, the profit margins may be smaller in some cases, and the savings to consumers less than the savings on generic versions of pills or tablets.

"Trying to do this from scratch without experience would be a challenge," Glorikian said. "You have to have the right people, the right facilities, to make it feasible. From a competitive standpoint, you'll probably want to bring a biosimilar onto the market at a lower price than a branded drug. But it's not a generic where you can make it significantly cheaper."

Biogen will manufacture Benepali for the European market at its plant in Hillerod, Denmark. Samsung Bioepis has awarded Biogen the rights to sell the rheumatoid arthritis drug in the European Union, Russia, Turkey, and Japan.

The parties haven't yet granted rights to sell the biosimilar in the United States, the world's largest single market, because Amgen's US patent protection on Enbrel — manufactured at its plant off Interstate 95 in West Greenwich, R.I. — runs through 2028.

Biogen owns 10 percent of its joint venture with Samsung but has an option that would allow it to boost its stake to 49.9 percent at an unspecified point in the future. While Benepali is their first biosimilar to win regulatory approval, the partners are collaborating in the development of other so-called anti-TNF treatments, which work to fight inflammatory diseases.

"We know how to make biologics, and we're pretty good at it," said Biogen's Seth. "We believe Biogen can compete very effectively in the market for highly complex, advanced biologics for the treatment of chronic diseases."