[Ip-health] USA Today on thwarting biosimilar competition

Steven Knievel sknievel at citizen.org
Fri Aug 5 12:08:43 PDT 2016


http://www.usatoday.com/story/news/politics/2016/08/04/biologic-drugmakers-patents-suits-generic-competition/87915734/  

Biologic drugmakers use patents, suits to thwart generic competition
Jayne O'Donnell, USA TODAY 5:47 p.m. EDT August 4, 2016

(Photo: Photo illustration by Thinkstock/Getty Images)
Prescription drug managers and researchers are calling for the use of essentially generic versions of high-priced drugs known as biologics, but they are meeting strong opposition from the drug industry and its subsidized patient groups.

On Tuesday, CVS Health said it will substitute two biologics with the generic versions known as biosimilars on its 2017 formulary, which is the list of drugs its benefit plans cover. Biosimilars lower prices by about 15%-30%, which is far less than generic drugs but still enough to attract insurers' attention.

CVS' announcement came as a new study found biosimilars were just as effective for the treatment of rheumatoid arthritis, psoriasis and inflammatory bowel disease as the higher-priced drugs, including Humira and Enbrel, authors from Johns Hopkins University and Brigham and Women's Hospital found.

If more drug benefit plans stop offering Humira and Enbrel in favor of biosimilars, it would jeopardize the drugmakers' cash cows. Abbvie's Humira, the top-selling drug last year, had international sales of more than $14 billion. Amgen's Enbrel, the third-highest-selling drug, saw sales of nearly $9 billion.

CVS, the second-largest pharmacy benefit manager (PBM) after Express Scripts, also owns the biggest chain of drug stores in the United States. Biosimilars and biopharmaceutical drugs - now known as biologics - are made from living organisms rather than the chemical compounds that comprise traditional medications.

This March 17, 2014, file photo shows a CVS/Pharmacy in Dormont, Pa. Until the merger of Rite Aid and Walgreen's is finalized, CVS is the largest chain of drugstores and is also the second-largest pharmacy benefit manager. (Photo: Gene J. Puskar, AP)

While some drug companies make both biologics and biosimilars, the industry generally has been arguing for a slow, cautious approach to biosimilar adoption in the United States. The CVS move, according to a statement by trade group Biotechnology Innovation Organization, is "coming between doctors and patients and potentially putting patient health and safety at risk."

Such claims are overblown, says Troyen Brennan, a physician and CVS' chief health officer. The formulary change "should be non-controversial," because the company reviewed the drugs with expert panels "to make sure they are considered equivalent." Biosimilars have been used with no reported problems for a decade in Europe.

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Europe lacks the same kind of reporting as the United States, so it's hard to know whether there have been negative results from using biosimilars, said Michael Reilly, executive vice president of the Alliance for Safe Biologic Medicines (ASBM). CVS' announcement is "just what we are concerned about," said Reilly, a former Department of Health and Human Services official under President George W. Bush.

Amgen, which makes the biosimilar drug for Humira and the biologic Enbrel, helps pay for ASBM. So do Genentech and patient groups, which also receive a lot of money from the drug industry.

Another patient group supported by the drug industry, the Global Colon Cancer Association, is raising similar concerns about biosimilars. "We want biosimilars to get to market," Andrew Spiegel says, but insurers switching patients without the consent of their doctor "has the medical and patient communities up in arms."

When his mother got colon cancer in 1998, Spiegel says there was only one drug - a generic - to treat it and the life expectancy was less than a year. Now there are about 10, including five biologics, and the life expectancy has tripled, which he says shows the importance of "innovative technologies and discoveries." Spiegel's father died of pancreatic cancer three days before his mother in early 1999.

Spiegel, an attorney, is the unpaid director of the association, which gets about half of its sub-$100,000 budget from drug companies. Drugmakers and patient groups have said pressure to reduce drug prices would discourage the industry from investing in research to discover life-saving drugs.

Neupogen, used to cut the risk of infection in patients receiving treatment for some cancers, will be replaced on the CVS formulary with the biosimilar Zarxio. CVS will also swap the insulin brand Lantus with Basaglar, which was approved in Europe as a biosimilar for the treatment of diabetes. Basaglar was approved here as a "follow on drug" by the Food and Drug Administration (FDA), a process that takes longer but carries similar weight.

Amgen's Neupogen sales internationally were down 9% to $1 billion last year and dropped 11% in the United States. Zarxio was introduced in the United States last September. Lantus, one of the top-selling drugs of all time, saw U.S. sales drop by more than 30% in the last year. It accounts for nearly 20% of overall new sales for Sanofi-Aventis Group last year.

After lobbying by the drug industry, about half of states have passed laws that require doctors to specifically prescribe the biosimilar for pharmacies to switch patients from a biologic. But critics say patients who have insurance plans using CVS Health as the PBM will have little choice but to use the biosimilar unless they want to pay the full price out of pocket.

Brennan says anyone who has a problem with a biosimilar could seek a "formulary exception" and, if approved, the drug would be covered in full.

USA TODAY
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All sides are waiting for biosimilar guidance expected by the end of the year from the FDA. The Affordable Care Act gave the FDA authority to approve biosimilars.

Bertrand Liang, chairman of the Biosimilars Council and CEO of biosimilar maker Pfenex, says drug companies will spend whatever it takes to protect their products from competition. (Photo: J.T. MacMillan )

Many health care experts say the pharmaceutical industry's resistance to biosimilars mirrors its opposition to generic drugs in the 1980s.

Among the efforts:

. Raising safety questions. Colon cancer patients are not going to back the approach of, "Let's just give it to everybody and hope that it works," says Spiegel. But that's just raising "unnecessary fears," says Mark Merritt, CEO of the PBM trade group Pharmaceutical Care Management Association. Drugmakers and patient groups are trying to create a negative perception right out of the gate," he says.

. Taking anti-competitive actions. American consumers are being forced to subsidize below-cost pricing in Russia by drugmaker Roche, according to a recent federal lawsuit that says Roche is trying to drive a biosimilar company there out of business to prevent it from selling here. That company, Biocad, has developed biosimilars for cancer drugs but Roche keeps lowering the cost of its drug, sometimes by as much as 80%, the lawsuit charges. Biocad has developed a biosimilar for the cancer drug Herceptin, which costs as much as $100,000 a year in this country.  "American cancer patients are paying for Roche to take out the competition," says Rika Khurdayan, a senior associate at Feinstein & Partners law firm. Genentech, which is part of Roche, asked the U.S. District Court for the Southern District of New York last week for more time to file a motion to dismiss the lawsuit.

. Filing multiple patents. Biologic makers have been "asserting many, many patents to protect their franchise," says Bertrand Liang, CEO of the biosimilar maker Pfenex and chairman of of the Biosimilars Council, which is part of the generic drug trade group. These and other drug companies are will "spend whatever it takes," said Liang. The New York Times reported recently that Humira maker AbbVie has more than 70 newer patents - most from the last three years - which the company expects will protect it from biosimilar competition until 2022.

"Everybody has been holding out for the promise(of biosimilars) for some time," says Brennan. "We hope that, over time, they will reduce drug costs substantially."


Steven Knievel
Campaign Coordinator | Access to Medicines Program
Public Citizen | Protecting Health, Safety and Democracy
TEL: +1 202-588-7769
1600 20th St. NW, Washington, DC 20009
URL: http://www.citizen.org/access  
Twitter: @PCMedsAccess

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