Saturday, August 1, 2015

Slow Saturday Special: Biogen Blues

I used to think it was more about medicine than money:

"Biogen loses $20 billion in value after revenue, profit forecasts cut" by Robert Weisman Globe Staff  July 24, 2015

Biogen Inc. learned a painful lesson about stock market gravity Friday, losing an astonishing $20 billion of value in a single day and giving back all its impressive gains over the past eight months.

Shares of Cambridge-based Biogen — the state’s most highly valued company — plunged 22 percent after executives reported disappointing quarterly earnings and lowered their financial forecasts for the immediate future. The share price dropped $85.02 to $300.03 over the course of the day.

The company’s news had followed a Wednesday presentation of mixed clinical results for the company’s highly anticipated experimental drug to treat Alzheimer’s disease.

I know there has been a lot to read regarding that subject lately, enough to keep one up at night, but their is the promise of progre$$.

Biogen had been one the stock market’s high fliers heading into this week. Reliably strong sales of its portfolio of multiple sclerosis drugs and the commercial potential of its Alzheimer’s treatment had boosted Biogen stock more than 25 percent since last November.

“A company that’s a hero one second can have a string of bad luck,” said Maxim Jacobs, senior health care analyst at Edison Investment Research in New York. “Biogen’s been a rocket ship, but now the stock’s fallen back down again.”

The enormous sell-off in Biogen shares appeared be driven mainly the company’s decision to reduce 2015 sales and profit guidance amid expectations of intensified competition for its top-selling MS drug, Tecfidera, a pill vying with an oral therapy marketed by Swiss drug maker Novartis AG. Tecfidera’s second-quarter sales fell short of analysts’ projections.

Biogen also reported lower quarterly sales for another MS drug, Tysabri, which the company said had failed to show benefits for stroke patients in a clinical trial that had sought to demonstrate that the treatment could be used against a different disease.

Investors also continued to digest the mixed data that Biogen released earlier on its Alzheimer’s drug candidate, which slowed the progression of the neurodegenerative disease, but also caused potentially dangerous side effects.

“We obviously have a lot of work ahead of us,” Biogen chief executive George Scangos conceded in a Friday conference call with stock analysts.

Shares of many other life-sciences companies also stumbled Friday. Molecular diagnostic firm Cepheid Inc. of Sunnyvale, Calif., lost more 10.6 percent, and biotech giant Gilead Scientific Inc. of Foster City, Calif., gave up 4.1 percent, as did Boston’s Vertex Pharmaceuticals Inc.

But the drop of Biogen, long considered an industry bellwether, was by far the steepest in the hard-hit sector, raising questions on whether the company could rebound in the near future.

“We’re very disappointed in the change of outlook for the year,” Biogen chief financial officer Paul J. Clancy said in the conference call. He suggested Tecfidera’s sales might be peaking in part because of concerns about a rare brain infection that last year was linked to a patient’s death.

“Nevertheless,” he said, “we remain committed to working tirelessly to turn around the commercial performance. And we’ll aggressively look for opportunities to reduce expenses while simultaneously ensuring we invest in the pipeline.”

But the company, which moved into a new headquarters building in Kendall Square last year and recently disclosed plans to build a drug-manufacturing facility in Switzerland, did not announce any plans to pare its workforce or research spending.

Related:

"The Massachusetts Institute of Technology launched a dramatic remake of a swath of Kendall Square on Tuesday, the latest effort to turn the bustling business district into a full-fledged neighborhood and meet the booming demand for more housing, offices, and research space. The broad reach of the redevelopment is MIT’s attempt to help solve challenges bedeviling Kendall Square, which has some of the most expensive rents on the East Coast, virtually no vacant office space, and a dearth of housing for the tens of thousands of people who work or go to school there."

“We have no plans for cutbacks at this time,” Biogen spokeswoman Kate Niazi-Sai said Friday afternoon after the conference call. “We’re committed to our programs.”

Among investors, the big loser from the company’s shrinking market value was Boston financial giants Fidelity Investments Inc., which owned 22 million shares, or more than 9 percent of the company, as of March 31. Fidelity had added 2.3 million shares to its Biogen holdings over the first three months of the year.

Better tell the ladies.

Another large investor, Wellington Management Co., had purchased 900,000 additional shares in the first quarter, according to regulatory filings. A smaller Boston investment firm, Westfield Capital Management, bought 320,000 shares of Biogen in the January-to-March period.

Investors were left wondering whether Biogen’s shares would fall further, recover in the coming months, or were fairly valued after Friday’s sell-off.

“If the [research] pipeline delivers, the upside would obviously be substantial,” Mark Schoenebaum, biotech and pharmaceuticals analysts for Evercore ISI in New York, wrote in a note to the firm’s clients.

Robyn Karnauskas, a biotechnology analyst for Deutsche Bank in New York, said she believed Biogen would resume growing. But in a note to investors, she acknowledged that “there are not many near-term catalysts” to propel the Cambridge company’s shares.

Jacobs, at Edison, said Biogen will need to reestablish the company’s identity with investors after the news of the past week.

“When the Alzheimer’s drug was up front, Biogen was a [product] pipeline story,” he said. “Then, after the disappointing Alzheimer’s data, Biogen was a product growth and Tecfidera story. Now that they’ve lowered their guidance for the year, what kind of story are they? People don’t know.”

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I guess the musical chairs in the front office didn't help:

"Biogen shares retreat amid executive shuffle, analyst warnings on drug data" by Robert Weisman Globe Staff  July 11, 2015

Biogen Inc. shares fell nearly 3 percent Friday amid the resignation of the company’s top research executive and a pair of reports by industry analysts about upcoming new clinical data on an experimental drug for Alzheimer’s patients.

Biogen stock fell $10.73 per share to $388.56 — even as the broader stock market and other biotech shares posted solid gains for the day.

The company said research chief Douglas Williams, who joined Biogen in 2011 to lead a restructuring of its drug discovery focus, will depart at the end of July to lead an as-yet unnamed cancer diagnostics and therapy startup.

A pair of senior vice presidents, chief medical officer Alfred Sandrock and chief scientific officer Spyros Artavanis-Tsakonas, will take over responsibility for research and development, the company said. A spokeswoman said neither Williams nor his successors would comment.

Biogen became the state’s most valuable company on the strength of its drugs to treat multiple sclerosis and hemophilia. But the company got an added stock market boost in March when it published early-stage clinical results showing an experimental drug slowed the mental decline of a small number of Alzheimer’s patients.

Two stock analysts issued reports Friday suggesting follow-up data Biogen plans to release July 22 at the Alzheimer’s Association International Conference in Washington, D.C., carries risks for investors.

Both analysts, however, maintained their “outperform” rating on Biogen’s stock. Neither specifically predicted negative information from the company’s ongoing study of patients with early indications and mild cases of the neurodegenerative disorder.

But the update on the Alzheimer’s drug candidate could “substantially alter the probability of success” for upcoming late-stage trials, as calculated by investors, and potentially move Biogen shares up or down as much as $50 each, analyst Eric Schmidt of Cowen & Co. wrote in a note to investors. Schmidt said his forecast “somewhat” favored a positive outcome but “we lack conviction.”

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You know what the $olution is? Move.

"Biogen plans $1 billion plant in Switzerland" by Robert Weisman Globe Staff  July 01, 2015

The Cambridge biotechnology giant Biogen Inc. plans to invest $1 billion in a new manufacturing plant in northern Switzerland that would triple the company’s global capacity to produce large protein-based drugs known as biologics.

Ah, the wonderful world of biologics.

The plan, which is subject to zoning approval by the Swiss government, could help reduce Biogen’s corporate tax rate to 23 percent from 26 percent, according to a note to investors by Robyn Karnauskas, a biotech analyst at Deutsche Bank.

Biogen spokeswoman Kate Niazi-Sai would not discuss the tax rate, but said, “there are economic benefits associated with this.”

The proposed site in Luterbach, Switzerland, near Zurich, would be Biogen’s fourth manufacturing plant. The company currently makes its portfolio of multiple sclerosis and hemophilia drugs in Cambridge, Research Triangle Park in North Carolina, and Hillerod, Denmark.

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“We’re preparing responsibly for future demand,” Niazi-Sai said of the proposed plant, which would create about 400 jobs. She noted that Biogen expects approval of experimental drugs in its pipeline and growth of its marketed drugs.

“We anticipate that it will increase our capacity significantly,” she said. “It’s part of a strategy to anticipate demand and to strengthen our drug-supply network in general.”

Niazi-Sai would not say which drugs Biogen plans to manufacture in Switzerland or specify the size of the plant. She said the plant will be the company's most productive, drawing on state-of-the-art biotech manufacturing technology.

Though the company has been based in Massachusetts for more than three decades, Biogen was founded in Geneva in 1978 and has deep roots in Switzerland. Its European headquarters are in the Swiss city of Zug, also near Zurich.

Daniel Bangser, a New York-based trade commissioner for the Switzerland Global Enterprise, a government agency for trade and investment, said Switzerland competed for the Biogen plant with other potential sites in Europe and the United States. Among the benefits of Switzerland, a European biopharma hub, is a skilled workforce and advanced infrastructure, he said....

We don't have that here?

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At least the Swiss don't have any sex scanda....

"Swiss paying many taken from parents" Associated Press  July 10, 2015

BERLIN — Swiss authorities have paid out $4.9 million so far to hundreds of people who as children were taken from their parents and sent to work on Swiss farms or placed in other homes.

The government-backed fund to support former ‘‘contract children’’ who face financial difficulties was set up last year.

Child labor in that rich country?

Many of those children experienced physical and sexual abuse from the adults who were supposed to care for them.

More than 1,300 applications for payouts were received by the June 30 deadline, the Justice Ministry said Thursday. About 600 of the 737 applications processed so far were approved, and the rest should be considered by the beginning of next year.

The practice of sending poor children to farms started in the early 1800s and continued until the 1960s, a period during which Switzerland was transformed from a rural backwater into a wealthy and modern society.

Officially, authorities only took children away from parents who were too poor to properly care for them. In practice, historians say, Swiss authorities also targeted the children of single mothers and others whom they considered to have fallen into ‘‘moral destitution.’’

The government is working on plans for a full compensation fund for all victims.

Switzerland’s regional and municipal governments, companies, private organizations, and individuals contributed to the existing fund for particularly needy recipients.

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Time to take a pill and a meeting:

"Some fear biotech reaching unsustainable heights" by Robert Weisman Globe Staff  June 15, 2015

Another bubble?

PHILADELPHIA — They continue to churn out life-changing drugs while investors shower them with billions of dollars. But as more than 15,000 executives gather for the biotechnology industry’s biggest convention, there is growing concern that the boom may be peaking.

“Everyone is terrified that this bubble is going to burst at any moment, so they’re looking for signs of a top,” said Michael Gilman, chief executive of Padlock Therapeutics Inc. of Cambridge and a venture partner at investment firm Atlas Venture. “People are starting to look over their shoulder now, and it won’t take much of a scare to cool down investors’ ardor.”

Those worries were tempering enthusiasm for the industry’s historic growth on the eve of the Biotechnology Industry Organization’s annual meeting, which opens Monday in Philadelphia. Sales, mergers and acquisitions volume, and research outlays all climbed to new heights last year....

Perhaps most worrying are some recent high-profile deals that seemed to spotlight the frothy state of biotechnology transactions. Much is at stake for Massachusetts, home to one of the largest biopharmaceutical clusters in the world. Every biotech in the Bay State and beyond is chasing what consulting firm Ernst & Young calls the “Gilead effect,” a reference to the Foster City, Calif., company whose sales more than doubled to $24.9 billion last year on the strength of Sovaldi, which can cure hepatitis C.

“Gilead was a bellwether for the industry,” said Glen Giovannetti, the Boston-based global life sciences leader at Ernst.

Yeah, it's a “business where the fuel is cash.”

That's where their partner comes in. 

As for the patients....

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Related:

"Joshua Boger, founder and former chief executive of Vertex Pharmaceuticals Inc. in Boston, however, said some of today’s venture firms are no longer willing to trust entrepreneurs on the trial-and-error methods that, in the first generation of biotech companies, often led to breakthroughs that were not part of the original plan. Recalling his own startup days at Vertex, Boger said his early investors “by and large did not question me on the science.” Today, by contrast, some venture firms will hire “23-year-old PhDs to try to outthink [entrepreneurs] in their field,” he said, adding, “I find this to be a disturbing trend.” 

Literally sucking the blood out of you.

"Doctors challenge Vertex over high price of cystic fibrosis drug" by Robert Weisman Globe Staff  July 20, 2015

California scientist Paul M. Quinton learned that he has cystic fibrosis at age 19 and has spent his long career in his lab working on ways to cure it.

He is, in short, not the kind of person you’d expect to be fighting with Vertex Pharmaceuticals Inc., the company developing a new class of breakthrough drugs for the obstructive lung disease.

But he and a group of prominent cystic fibrosis doctors are doing just that. For the past three years, they have engaged in a private and largely fruitless dialogue with Vertex over their complaints that the Boston biotechnology firm is overcharging for its medicines.

Now, nearly three weeks after Vertex won US approval for a two-drug therapy called Orkambi that eventually could treat roughly half of the 30,000 Americans with cystic fibrosis, Quinton and his medical colleagues are going public with their objection to the company’s decision to price the drug at $259,000 per patient annually.

“It’s egregious,” Quinton, 70, a professor of biomedical science at the University of California at San Diego, said in an interview. “This is more than five times the annual salary of the average American family. How can they in good conscience charge that much?”

The question resonates with health insurers and consumer groups that have raised alarms about the soaring prices of specialty therapies for everything from cancers to rare genetic disorders. Vertex’s prices have come under scrutiny, initially in a 2013 article in a leading medical journal, partly because they seemed to crystallize the broader debate over how to hold down health costs while rewarding makers of treatments for relatively small numbers of patients.

Vertex spokesman Zach Barber said the company, which has lost money in all but one of its 26 years, has invested billions of dollars in its cystic fibrosis program. Vertex needs to generate the revenue and profit that will enable it to expand the market for Orkambi worldwide and develop treatments for cystic fibrosis patients with other mutations, Barber said.

Then what is with the huge paydays for executives?

“Right now, two-thirds of the patients in the United States don’t have medicines’’ to treat the cause of the cystic fibrosis, Barber said. “We want to help those people. That work is going to take a very long time, hundreds of people, and a very significant continued investment.’’

Dr. Brian P. O’Sullivan, a pulmonary specialist at Dartmouth-Hitchcock Children’s Hospital in New Hamphire, is one of those who joined Quinton in meetings with Vertex executives. He said the group is concerned not only about the cost of Orkambi and Kalydeco, another Vertex cystic fibrosis drug priced at more than $300,000 a year, but about the cost of specialty drugs of all kinds.

“This is not sustainable,” said O’Sullivan, who until recently taught at the University of Massachusetts Medical School in Worcester. He said he hopes to bring the issue of high drug prices to larger groups of specialists in cystic fibrosis and other medical fields.

“As we move into genomics medicine, diseases are being divided into smaller pieces based on genetic mutations, and the prices to treat each of the pieces is exceedingly high,” O’Sullivan said. “I don’t think that health care can be treated like a commodity the way a car is.”

The Food and Drug Administration initially approved Orkambi for a population of only about 8,500 patients age 12 and over with the most common cystic fibrosis mutation. Vertex already has begun making the treatment available to those patients and is testing it on Americans under 12 and on subsets of patients in other countries with the same mutation. Its other drug, Kalydeco, treats about 2,000 cystic fibrosis patients with a different mutation.

Patients don’t typically pay for drugs out of their own pockets. About 35 percent of those now eligible for Orkambi are insured by Medicaid, the government program for low-income residents. Most of the rest are covered by private insurers. But even when insurers foot most of the bill, patients are responsible for often hefty deductibles and copays. And the drugs contribute to a health care system that is increasingly expensive for everyone.

Obummercare was supposed to cure that.

Vertex says its aim is to make sure every patient who is eligible for Orkambi can get it. The company has launched a program to provide the drug free to uninsured patients and subsidize copays for qualified insured patients.

In a conference call after the FDA approval, Vertex chief commercial officer Stuart Arbuckle cited four factors in justifying Orkambi’s price: a small patient population, the clinical benefit of a drug combination that treats the underlying cause of the disease, the time and cost of Vertex’s efforts to bring the medicine to market, and the need to invest in research to develop other therapies for tens of thousands of patients with other forms of cystic fibrosis.

“It is highly expensive and risky,” Arbuckle said.

Quinton and his associates are quick to note that other parties, including the US government and a private foundation, helped fund early research on Vertex’s medicines. In the 1980s, in his federally funded lab, Quinton himself made a discovery — identifying a basic defect in the sweat glands — that was a building block in research that led to cystic fibrosis drugs. While he said he doesn’t believe he should profit from his own contribution to cystic fibrosis therapies through publicly funded research, Quinton questions the compensation to executives who he said got involved in the drug program much later. “It just seems wrong,” he said.

Quinton said he is particularly upset about Vertex’s board awarding more than $53 million in one-time bonuses to a dozen senior executives. The payouts would not come until the end of 2017 at the earliest, and only after the company posted profits for the previous four quarters. Analysts say this is a likely scenario given their sales projections for Orkambi.

“What we’ve done is essentially make the executives a bunch of millionaires,” said Quinton, who takes Vertex’s Kalydeco to improve his breathing and who runs a lab focusing on cystic fibrosis at the University of California at San Diego.

Quinton, O’Sullivan, and other cystic fibrosis specialists, including Dr. David Orenstein at the Children’s Hospital of Pittsburgh and Dr. Mark Pian, a San Diego doctor who is former director for the cystic fibrosis center at the University of California at San Diego, first raised the issue of Vertex’s pricing after Kalydeco entered the US market in 2012.

They corresponded by e-mail with company leaders, including chief executive Jeffrey M. Leiden, and personally brought their concerns to Leiden and his lieutenants in private meetings during North American Cystic Fibrosis Conferences in Orlando in 2012 and Atlanta last fall.

At the meetings, they recall, Leiden invited them to support Vertex in its campaign to find treatments for almost all types of cystic fibrosis by 2020. But he also made it clear, they said, that Vertex needed to generate the revenue that would let it invest in other profitable drugs. They said he warned that lower prices could make the company vulnerable to a takeover by a pharmaceutical giant with less interest in pursuing cystic fibrosis drug development.

Quinton and the cystic fibrosis doctors say they also proposed that Leiden and other Vertex executives address the price issue before a larger forum or in a webcast that would be open to doctors and patients via the Internet, but nothing came of the idea.

“We really saw that the bottom line was what the market would bear,” Orenstein recalled. “He [Leiden] said every year they were in the red and Wall Street has only so much patience and no more.” Orenstein conceded that he and his colleagues don’t know what the price of a drug like Orkambi should be. “We’re not health economists,” he said.

Barber, the Vertex spokesman, said that in the meetings Leiden sought to communicate the company’s goal of becoming a sustainable and independent business. But he denied the Vertex chief executive said that drugs were being priced to Wall Street expectations.

In October 2013, about a year after they first met with the Vertex executives, O’Sullivan, Orenstein, and Dr. Carlos E. Milla at the Stanford University School of Medicine coauthored an article in the Journal of the American Medical Association criticizing the pricing of drugs for rare diseases. The article centered on Kalydeco, which had been introduced the previous year. Vertex had set Kalydeco’s price at $294,000 per year and increased it to $311,000, they wrote.

“The vast majority of patients cannot afford this financial burden, and transferring the cost to private or federal insurers does not obviate the underlying problem — an unsustainable pricing structure,” they wrote. They also noted that, as with most drug development programs, Vertex didn’t develop Kalydeco alone. The National Institutes of Health and other funders, including the Cystic Fibrosis Foundation, helped underwrite basic research and subsequent development at Vertex and a company it acquired, Aurora Biosciences Corp. of San Diego.

A spokeswoman for the Cystic Fibrosis Foundation wouldn’t comment specifically on the price of Orkambi. But in a statement, the foundation said that the cost of doctors, hospitals, drugs, and diagnostics together places “a tremendous financial burden on people with the disease and their families.”

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RelatedFDA clears Vertex’s new treatment for cystic fibrosis

Also see:

Genzyme will expand, take a new name

Genzyme to buy thyroid cancer drug from AstraZeneca for $300 million

How Genzyme became a source of biotech executives

Look who skipped the meeting:

"Charlie Baker, top state officials skip biotech meeting; But state says its support still strong" by Robert Weisman Globe Staff  June 17, 2015

PHILADELPHIA — As governor, Deval Patrick used the biotechnology industry’s premier convention as a launching pad for one of his highest-profile business-development initiatives. But neither Governor Charlie Baker nor any of his top economic officials are making the trip to this year’s Biotechnology Industry Organization convention, at which a large Massachusetts pavilion opened Tuesday.

It fell to Pamela Norton, the usually low-profile vice president of industry relations and programs at the Massachusetts Life Sciences Center, to gamely represent the state at a news conference unveiling a new Internet portal linking biotech companies around the world with academic researchers at teaching hospitals from Boston to Worcester. Her former boss, center president Susan Windham-Bannister, stepped down this spring, and the Baker administration has yet to announce a successor at the quasi-public agency.

“Normally, I’m behind the scenes,” Norton said afterward.

While governors from Delaware and South Dakota appeared Tuesday at the BIO convention to drum up business in the hopes of building their own biotech clusters.

The contrast to years past was striking. In 2008, Patrick launched a major initiative to support the life sciences industry in Massachusetts and promptly led a big state delegation to the biotechnology convention, where he was named BIO Governor of the Year. In later years, Patrick was a reliable presence on the convention exhibition floor, pressing the flesh of out-of-state drug manufacturers as the Bay State’s salesman in chief.

Paul McMorrow, spokesman for the Executive Office of Housing and Economic Development, insisted support for the biotech industry has not diminished under the Baker administration.

Patrick had committed more than $600 million to tax breaks, working capital grants, and other incentives to attract companies to locate or expand in Massachusetts....

Plus he borrowed a billion to hand out to profitable pharmaceuticals, costing the state hundreds of millions now going to debt service payments.

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Related:

"Governor Charlie Baker will channel his inner Hulk Wednesday and join the chief executive of a Danvers biotechnology company in smashing through a wall to expand its headquarters. Abiomed Inc., with a global workforce of about 650, is taking over the space next door. The company’s main product is a thin pump used during medical procedures to temporarily help recovering hearts pump blood. Chief executive Mike Minogue said the company would add 80,000 square feet and 100 manufacturing and engineering jobs during the next two years."

Those drugs were so strong they practically knocked me out.

NEXT DAY UPDATE:

"Big money hinges on rules for names of biotech generics" by Tracy Jan Globe Staff  July 11, 2015

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.

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.

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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.”

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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....

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.”

A provision to allow generic competition for biotech drugs was included in the 2010 Affordable Care Act.

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.... 

For your good health, of cour$e!

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Also see: Over the Verizon