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Big money hinges on rules for names of biotech generics

Novartis

WASHINGTON — As he listened to dire warnings from Amgen Inc. and its well-funded allies over the safety of generic copies of expensive biotech drugs, Dr. James Liebmann said he detected another powerful motivator at work: profit.

Liebmann, a Massachusetts oncologist, is a member of a drug advisory panel of the US Food and Drug Administration. One after another, during a meeting this year, a parade of patient advocates backed by pharmaceutical companies said different generic names should be required to distinguish the cheaper versions of biotech drugs in case they cause dangerous side effects.

It’s as if the makers of Advil and Motrin argued that generic versions of the painkiller shouldn’t be called “ibuprofen,’’ so doctors and patients trying to track safety issues won’t be confused.

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What’s in a name? Billions upon billions of dollars in potential savings for US health insurers and consumers.

If the FDA allows the new generation of biotech drugs to adopt the same generic name and encourage competition, analysts say growth in US health care costs will slow.

Amgen — which sells Neupogen, the first brand-name biotech drug to face generic competition in the United States — is the test case for this precedent-setting rule. Amgen argues that competitor Sandoz should not be permitted to market its version of the drug as “filgrastim,’’ the generic name for Neupogen.

The FDA is taking the argument seriously, but critics like Liebmann aren’t buying it. They say it’s a scare tactic intended to discourage doctors from prescribing lower-cost generic alternatives.

“It has nothing to do with whether or not the Sandoz product is identical,” said Liebmann, a University of Massachusetts oncologist.. “It has everything to do with trying to protect market share.”

Geoff Eich, an Amgen executive, said the company is simply trying to protect patients. “An inability to identify specific biologic medicines reliably jeopardizes all biosimilar products equally,” he said.

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Biotech drugs, manufactured from living proteins, have much larger molecules than conventional drugs. They are used to treat life-threatening and chronic diseases such as cancer and multiple sclerosis, and are among the most expensive pharmaceuticals on the market, with treatments ranging from $16,000 a year per patient for anemia to upwards of $600,000 a year for hemophilia.

Generic drugs, available for decades, are copies of brand-name drugs whose patents have expired, and thus, cost significantly less. That competition is now coming to the world of biotech medicine.

Express Scripts, the nation’s largest pharmacy benefits manager, projects US spending on biotech drugs to reach $120 billion by 2024 without robust generic competition, up from $35 billion in 2014.

A 2014 study by Rand Corp. that was sponsored by Sandoz, estimated that these “biosimilars,’’ as they are known by regulators and industry insiders, could reduce US health care costs by $44 billion over the next decade

“Biosimilars have an important role as a pressure valve to relieve some of the increasing drug costs,” said Ronny Gal, an analyst covering the specialty pharmaceutical industry at Sanford C. Bernstein, an investment research and management company. But “innovators are doing their best to create barriers for adoption of biosimilars in order to slow down the erosion of their product.”

The FDA has already determined that a biosimilar can have “no clinically meaningful differences’’ in terms of safety or effectiveness.

But the wiggle room for Amgen and other manufacturers of brand-name biotech drugs that are trying to shape the final rules stems from the characteristics of these drugs. Even though the original drug and the generic competitor are essentially the same, biotech drugs have more variability than traditional drugs created from chemical compounds. Some say biosimilars should not even be referred to as generics, because they are not scientifically the same.

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“Biosimilars are not biosames,” one patient advocate, a former industry consultant, said at the January FDA meeting, according to the transcript.

Among those pushing for different names are the Biotechnology Industry Organization, the industry’s Washington-based lobbying group; and Massachusetts’ major biotech companies, including Biogen Inc., of Cambridge, and AbbVie Inc., which has a research center in Worcester.

“For biologics, it’s important we be able to tell quickly which product is responsible for the side effect,” said Emily Alexander, AbbVie’s director of external affairs.

Generic biotech drug makers say they have been able to use the same generic naming system in Europe for almost a decade. They note there are multiple ways to trace a drug’s origination in cases of adverse events, such as brand name, manufacturer name, lot number, and a unique national drug code.

These companies say that doctors need to understand that the only meaningful difference will be the lower price.

“The naming issue is really a red herring,” said Christine Simmon, senior vice president for policy at the Generic Pharmaceutical Association, which lobbies on behalf of generic drug makers. “Innovator companies have an interest in sowing seeds of doubt.”

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A provision to allow generic competition for biotech drugs was included in the 2010 Affordable Care Act. The promise of a lower-cost competitor came closer to reality in the US in March, when the FDA approved Sandoz’s Zarxio, which, like Amgen’s Neupogen, stimulates white-blood cell production in the body to restore infection-fighting capability in people undergoing chemotherapy or bone-marrow transplants.

Liebmann, who had reviewed Zarxio’s FDA application and recommended the drug for approval, said its chemical structure is identical to the Amgen product. “It should be named filgrastim because to not call it what it is is misleading,” Liebmann said.

Express Scripts estimates that Zarxio alone, expected to cost at least 30 percent less than Neupogen, will save the US health system $5.7 billion over the next decade. Neupogen, whose patent expired in 2013, generated $839 million in US sales for Amgen last year.

Amgen has temporarily blocked Zarxio sales with a lawsuit, charging that Sandoz failed to share its complete FDA application with Amgen, which the company contends the law requires.

Amgen, headquartered in Thousand Oaks, Calif., operates a research lab in Cambridge’s Kendall Square. Sandoz, based in Germany, is the generics division of Swiss drug maker Novartis AG, whose biomedical research headquarters are also in Cambridge.

For now, the FDA has designated a placeholder generic name for Zarxio — filgrastim-sndz, the suffix standing for Sandoz — which the agency said is not reflective of a comprehensive naming policy for such drugs. FDA officials declined interview requests, saying the agency is expected to issue its rules on naming by the end of the year.

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Amgen, which has developed 12 original biotech drugs, is also creating biosimilars to compete with other brand-name drugs, said Eich, executive director of Amgen’s biosimilars division.

Eich said Amgen favors a distinguishable generic name for all biosimilars, including its own. “It this were bad for biosimilars, it would hurt us,” he said. “But it’s not bad for biosimilars.”

Much of this battle is waged by proxy, with industry-funded groups submitting letters to regulators and writing reports to try to shape public opinion.

The Alliance for Safe Biologic Medicine pushed the FDA in May for a different biosimilar naming system. The organization is backed by big pharma, with Amgen, Genentech Inc., and the Biotechnology Industry Organization listed as partners on its website.

An Amgen spokesperson said the company does fund some patient groups, but it does not have influence over many others advocating for different generic names.

Peter Pitts, president of the Center for Medicine in the Public Interest, penned a newspaper editorial last month urging Congress to instruct the FDA to develop a naming system to distinguish generic biological drugs “before patients get hurt.” At stake, the former FDA official said, “could be the difference between life and death.”

Pitts’s organization receives funding from pharmaceutical companies and often defends the industry, but he said industry money does not influence his views.

“I don’t see how pharmaceutical companies have undue influence when they themselves are also manufacturers of biosimilars,” Pitts said in an interview. “It’s a thing people say to taint patient groups who are really trying to do the right thing.”


Tracy Jan can be reached at tracy.jan@globe.com .