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Biosimilars pose significant dollar threat to biotech cos.

BY Alaric DeArment

WALTHAM, Mass. —The healthcare-reform bill that passed in the House in November has generated controversy throughout the country, but biotechnology companies may have reason to feel nervous.

According to a report from healthcare market research firm Decision Resources released early in November and titled “Biosimilars: TNF-Alpha Inhibitors and Interferon-Alphas in Immune and Infectious Diseases,” makers of tumor necrosis factor-alpha inhibitors for treating autoimmune disorders stand to lose $9.6 billion in sales in the United States, France, Germany, Italy, Spain and the United Kingdom by 2018 to biosimilar competitors, with increasing pressure on physicians from payers looking to save money. The report specifically named Amgen’s Enbrel (etanercept), Abbott’s Humira (adalimumab) and Remicade (infliximab) by Johnson & Johnson and Schering-Plough Corp., now part of Merck & Co.

The catch, of course, is that the United States currently has no regulatory approval pathway for biosimilars, and the Senate had yet to vote on its version of the healthcarereform bill at press time. Even if it had, several years most likely will pass before the first biosimilars appear on the U.S. market, as both the House and Senate bills provide for 12 years of data exclusivity. The Senate version would require an additional six months before the Food and Drug Administration could approve a biosimilar for children.

Meanwhile, in Europe, the only biosimilars on the market are follow-ons of Amgen’s anemia treatment Epogen (epoetin alfa) and chemotherapy side effect treatment Neupogen (filgrastim), and Pfizer’s growth hormone deficiency treatment Genotropin (somatropin [rDNA origin]).

“I think that you’re going to see virtually no biosimilar activity in the United States, with the exception to the human growth hormones that we have, until the beginning of the next decade,” IMS Health VP industry relations Doug Long told Drug Store News, referring to Omnitrope, a biosimilar version of Genotropin made by Sandoz, for which the FDA granted special approval in 2006. Long said biosimilar TNF-alpha inhibitors probably would begin appearing in Europe between 2011 and 2013. Monoclonal antibodies for treating cancer, and interferons for treating infectious diseases and certain cancers could appear down the line as well.

Whatever the time frame, the Decision Resources report illustrated the environment in which biotech companies could find themselves in the event of robust competition from biosimilars. Of the three TNF-alpha inhibitors specifically mentioned, Enbrel is one of the top-selling drugs in the world, with $5.7 billion in global sales, according to IMS data. On the whole, autoimmune drugs had global sales of $15.9 billion.

Physicians’ feelings about biosimilars also could influence the market. The Decision Resources report showed that gastroenterologists and rheumatologists had a “conservative” attitude toward biosimilar use relative to other specialists, but that discomfort with biosimilar TNF-alphas inhibitors would not prevent them from prescribing the drugs. They also would consider pressure from cost-conscious payers a motivating factor. “For the second year in a row, surveyed U.S. payers rank TNF-alpha inhibitors as their top priority for reducing biologics spend,” Decision Resources analyst MaryEllen Klusacek stated. “We anticipate that payer pressure on physicians to prescribe biosimilar TNF-alpha inhibitors will be high.”

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Hy-Vee names new president

BY Alaric DeArment

WEST DES MOINES, Iowa A 28-year employee of Hy-Vee has become its new president, according to published reports.

The company appointed Randall Edeker as president of the supermarket chain Thursday at the company’s annual meeting, succeeding Ric Jurgens, who had served as president since 2001 and will maintain his position as chairman and CEO.

Edeker had previously served as EVP and COO.

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Tricare expands vaccination coverage to pharmacies, clinics

BY DSN STAFF

NEW YORK Convenience and value. That’s what community pharmacy and their retail clinic partners deliver to their patients. And that’s what the Department of Defense is counting on in covering immunizations at local pharmacies and identifying convenient care clinics as network providers — two separate pieces of news issued within the past month that really underscore the importance of pharmacies and retail clinics in the delivery of health care today.

Prior to these announcements, military personnel interested in getting their flu shots had to schedule an appointment with their doctor, as Tricare only covered the cost of shots delivered in a doctor’s office.

“As a convenient and accessible healthcare provider, pharmacy is uniquely positioned to offer services for patients, such as vaccinations,” stated Steve Anderson, president and CEO for the National Association of Chain Drug Stores. Anderson noted that as of earlier this year, pharmacists have the ability to immunize patients in all 50 states. “[This] presents an important opportunity for pharmacists to counsel patients during their visit, and an additional healthcare provider from which to obtain these vaccinations.”

It’s also quite a bit of opportunity for pharmacy — Tricare provides healthcare coverage for 9.5 million eligible beneficiaries. Those beneficiaries pick up almost 2.3 million prescriptions every week, and 1.2 million of those at retail pharmacies, according to Tricare .

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