The Journal Gazette
Sunday, July 16, 2017 1:00 am

Fighting to keep patents

Drugmakers say new complex biosimilars need protection

Doni Bloomfield | Bloomberg News

BOSTON – Drugmakers plunged off a patent cliff earlier this decade, losing billions in sales as lucrative branded drugs lost exclusivity. An expensive lobbying effort aimed at preventing a repeat is paying off.

The loss of a series of key patents for cholesterol fighters and other widely used medicines cost big-name drug companies about $82 billion in sales between 2011 and 2013, according to life-sciences data company Evaluate Ltd., forcing large-scale job cuts and a wave of deals to make up for lost revenue.

Once again, the pharmaceutical industry is peering over the ledge. Over the next three years, roughly $60 billion of drug sales for companies including Roche Holding AG, Sanofi, and Eli Lilly & Co. is threatened by potential rivals, according to a report from the investment firm Sanford C. Bernstein & Co. Among the drugs expected to lose their protections are pricey biotechnology treatments for cancer and other diseases.

The industry has pushed hard to forestall generic competition for the complex drugs, which are typically grown from cells rather than manufactured chemically. As Congress debated a new approval process for biosimilars amid the legislating of the Affordable Care Act, the industry boosted its lobbying by almost 50 percent, spending $274 million in 2009, according to the Center for Responsive Politics.

By the time lawmakers passed a path to market for biosimilars as part of the Affordable Care Act in 2010, the industry had assured that competition would come much more slowly, making the resulting sales decline look less like a precipice and more like a gentle hill.

High stakes

Swiss drugmaker Roche may have the most at stake. It's facing the loss of exclusivity for its three top-selling cancer drugs over the next two years, which account for more than $20 billion of its $51.4 billion in annual sales. Roche's leukemia therapy Rituxan, which sold $7.24 billion last year, loses patent protection this year, according to Bernstein. Out of 31 analysts who follow Roche's stock, 21 rate it a “buy,” according to data compiled by Bloomberg.

Roche campaigned mightily for tougher approval for biosimilars. The company spent $17.7 million in U.S. congressional lobbying in 2007 and 2008, compared with $3.7 million in 2000, according to the Center for Responsive Politics. The surge was aimed largely at laws that would have created an easier path for biosimilars. Versions of those laws ultimately passed in the Obamacare law, but drugmaker lobbying helped ensured stiff barriers to entry and a longer period in which biosimilar makers couldn't cite earlier data when seeking approval.

“Roche is the strongest, biggest player which deliberately stayed out of biosimilars and is going out of its way to portray biosimilars as different and unsafe,” said Ian Tzeng, a partner at L.E.K. Consulting, a firm that consults with businesses about strategy and mergers and acquisitions.

Roche said in an emailed statement that it has supported “a rigorous and science-based pathway for the approval of biosimilars,” and that its lobbying has focused on ensuring that biosimilars are safe.

More complex

In the early 2000s, treatments for common chronic ailments racked up impressive sales for the world's biggest drugmakers. Blockbusters like cholesterol drug Lipitor, which peaked at $12.9 billion in sales in 2006 for Pfizer Inc., drove large gains in sales and profits. But after Lipitor's protection against generic competition lapsed in 2011, the geyser of cash it once generated evaporated. By 2016, sales were $1.76 billion, down 86 percent from their high.

“When Lipitor went off patent, the sales disappeared in a nanosecond,” said Roger Longman, CEO of Real Endpoints, which focuses on how to value drugs.

Lipitor and single-molecule drugs like it were straightforward for generics makers to copy. Many of the drugs expected to lose their patent shields in coming years, by contrast, are complex medicines produced by living cells, which makes replicating them more difficult.

Drugmakers' main lobbying groups, PhRMA and BIO, successfully watered down efforts to give biosimilars an easier approval process. They argued that making exact copies of biologic drugs would be virtually impossible given the technical hurdles to duplicating the medicines' large proteins, which are produced by genetically engineered cells in specialized vats.

PhRMA said it supported the law, which “balances the desire for increased competition among biologics from biosimilar products with the need for incentives to support future medical innovation,” said spokesman Andrew Powaleny by email.

Patent slope

Analysts say that given the longer approval arc for biosimilars, major drugmakers are less likely to be whipsawed by generic rivals when key medicines drop off patent. But over time, political pressure over high drug costs is expected to undercut the dominance of branded biologic drugs. The Food and Drug Administration's new leader, Scott Gottlieb, has said he wants more alternatives to brand-name medicines on the market to push down prices.

Also likely to shield drugmakers from a jarring sales slump are patients already taking biologic drugs who will resist switching, according to Ira Loss, a health-care analyst at research firm Washington Analysis LLC. But new patients may be forced to take biosimilar versions of drugs, and eventually that will turn the tide, he says.

“Ultimately, biosimilars are going to be a big part of our society — they have to be for cost reasons,” Loss said.

In the seven years since Congress passed the biosimilar approval legislation, the U.S. has approved five biosimilars, short of the 25 such drugs now approved in Europe, where regulators have resisted the industry's lobbying muscle. The slow path to market in the U.S. has frustrated makers of biosimilars and patients who hope the presence of more competitors will cause drug prices to decline.

“While Europe was acting, we were talking,” said Chip Davis, chief executive officer of the Association for Accessible Medicines, the generic drugmaker industry body. “We think there's an enormous amount of work to be done to get the pathway and market up and running. Year over year we are falling farther behind Europe, not catching up.”


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