HEALTH

Biosimilars’ future predicted to be as uncontroversial as generics

BY Alaric DeArment

NEW YORK —Biosimilars, biogenerics, follow-on biologics—whatever the designation one prefers for knockoffs of biotech drugs—they will soon become a part of the American healthcare system.

The healthcare-reform bill contained a provision creating an abbreviated regulatory approval pathway for follow-on biologics—albeit one that requires the Food and Drug Administration to wait until the innovator biologic has been on the market for 12 years before approving the follow-on version, rather than the five-year market exclusivity period used for generic pharmaceutical drugs.

Of particular interest is the case of Lovenox (enoxaparin sodium), a form of the blood thinner heparin, and the marketing of a generic version by Sandoz, which manufactures the drug under a partnership with Momenta Pharmaceuticals. Sandoz, the generics division of Swiss drug maker Novartis, won approval from the FDA to market generic Lovenox in July, and Sanofi sued to halt Sandoz, saying the FDA had acted improperly in granting approval, but a federal judge ruled in favor of Sandoz and the FDA. The catch is that though Lovenox received FDA approval in March 1993 as a pharmaceutical, many experts consider it a biologic due to its chemical complexity, and the FDA required testing for potential issues like allergic reactions before it would approve the generic version. For that reason, many experts said, the case of generic Lovenox could have a major influence on the regulatory approval process for follow-on biologics.

But after the market does take shape, it could eventually look increasingly more like the generic drug market, director Michael Malecki of industry research firm Decision Resources told Drug Store News. Malecki expected follow-on biologics’ initial effect on pricing to be small, at least until biosimilar monoclonal antibodies begin reaching the U.S. market, but that the market will take off over the next decade. “Over the next 10 or so years, we will be seeing a lot of marketing on the part of branded and biosimilar companies trying to shape the landscape,” Malecki said. “Biosimilar companies will claim that their products are just as safe and effective as brands, and some brands will try to counter that argument.”

In around 20 years, Malecki said, biosimilars could be as uncontroversial as generic drugs. “At some point in the future, biosimilars will be regarded analogously to small-molecule generics,” he said. “The questions are how long that change will take and what will be the ‘shape of the curve’ between now and then.”

In the meantime, some companies aren’t waiting and are seeking approval for biosimilars under the normal approval process. In February, for example, the FDA accepted Teva Pharmaceutical Industries’ application for XM02, a biosimilar of Amgen’s Neupogen (filgrastim) that it already markets in Europe under the name TevaGrastim. Teva is seeking approval for the drug as a treatment for lowered counts of white blood cells called neutrophils, also known as febrile neutropenia, in patients receiving chemotherapy.

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Dr. Siegal’s Cookie Diet introduces CalciOs

BY Allison Cerra

VIENNA, Va. Dr. Siegal’s Cookie Diet has expanded its offerings to include calcium-fortified cookies designed to treat occasional heartburn.

CalciOs cookies are vanilla-flavored cookies, each one providing 30% of the daily value of dietary calcium, Dr. Siegal’s Cookie Diet said. The cookies contain calcium carbonate, designed to treat heartburn relief. CalciOs also are free of artificial colors and preservatives.

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Pharmacies should get out of tobacco-selling, into smoking-cessation game

BY Antoinette Alexander

WHAT IT MEANS AND WHY IT’S IMPORTANT The news that San Francisco’s board of supervisors gave preliminary approval to ban tobacco sales at all retailers that operate pharmacies, including mass merchants and grocers, is a step in the right direction, because if drug stores are going to be banned from selling them, then all retail pharmacy outlets should be banned. However, there’s an even bigger picture to consider.

(THE NEWS: Report: San Francisco supervisors OK tobacco sales ban at pharmacies. For the full story, click here)

As many dollars as pharmacy retailers made selling cigarettes, there is much more to be gained in medication therapy management, and there is a significant opportunity for retail pharmacy to have a greater stake in the future of health care.

Cigarette smoking has been identified as the most important source of preventable disease, illness and death worldwide, according to the American Lung Association. Smoking-related diseases claim an estimated 443,000 American lives each year, including those affected indirectly by "secondhand" smoke.

Furthermore, smoking-related healthcare expenditures are a major drain on the U.S. healthcare system. According to the Centers for Disease Control and Prevention, smoking cost the United States more than $193 billion in 2004, including $97 billion in lost productivity and $96 billion in direct healthcare expenditures, or an average of $4,260 per adult smoker.

Clearly, there’s a positive role that pharmacists can play in smoking cessation. To further support this, a recently published study on the "effect of a pharmacist-managed smoking-cessation clinic on quit rates" found that pharmacists can play a vital role in smoking cessation, especially in a group setting, as they can reach more people within the same time frame.

The study found that at three months and six months, 47.6% and 52.4% of patients reported being smoke-free, respectively. The study was conducted on patients that had participated in the pharmacist-managed Smoking Cessation Group Clinic at the University of Iowa Hospitals and Clinics. Participants received structured group counseling on various topics associated with cessation.

It also should be noted that in August, the Centers for Medicare and Medicaid Services announced that Medicare coverage for seniors trying to quit smoking was expanded to include everyone on Medicare.

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