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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Re-evaluating Chinese currency remains a bad idea

BY Alaric DeArment

WHAT IT MEANS AND WHY IT’S IMPORTANT Herbert Hoover is alive and well — and picking up his prescriptions at the local drug store.

(THE NEWS: Retailers urge Congress to reject Chinese currency legislation. For the full story, click here.)

Of course, he isn’t. But if he were, he might have some advice to offer current members of Congress and occupants of the White House based on his experience with the Smoot-Hawley Tariff Act of 1930, which attempted to rescue the U.S. economy by imposing tariffs on imported goods, but instead ignited a trade war that many historians blame for deepening the Great Depression.

The legislation to impose tariffs on Chinese imports as a way to force it to revalue the yuan is based on the assumption that China manipulates its currency to make its manufactured goods more competitive in the U.S. market. Thus, the reasoning goes, if China were to revalue the yuan, it would help American manufacturers by making Chinese imports more expensive and American goods more competitive in China, thereby helping to ease the U.S.-China trade deficit, which totaled $226.9 billion last year and has so far reached more than $145 billion this year, according to U.S. Census data.

But it’s not that simple. In 1930, the United States manufactured most of its own consumer goods; but that’s no longer true, and the bulk of consumer goods, from toys to digital cameras, now come from China. Also frequently lost in the melee is the fact that most of the supposedly Chinese goods are not Chinese at all, but rather products with American, Japanese, Korean and European brands that are assembled in China. Unlike in the 1970s and 1980s, when such Japanese companies as Sony were eating the lunch of such American counterparts as General Electric, the “Made in China” label now graces the products of both.

For that reason, if legislators imposed big tariffs on Chinese goods or if China dramatically revalued the yuan, it would simply force retailers to pass the extra costs to consumers. So after picking up his prescriptions, Hoover would find the digital camera he had planned to buy from behind the counter noticeably more expensive. While this would not likely lead to another Great Depression, it would certainly diminish consumers’ purchasing power.

As for the manufacturing jobs, many experts have said they would simply migrate to cheaper countries rather than returning to the United States. This trend already is under way in textiles, as many clothing companies have started moving factories from China to such countries as Bangladesh in response to the increasing costs of manufacturing in China.

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j.hoston says:
Mar-20-2013 04:21 am

A brief introduction and definition on quality organization systems significance of quality, quality audits, audit objective, process of auditing & quality control tackle. Quality Audit Bangladesh

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Perrigo seeks approval for generic Zegerid OTC, Schering-Plough files suit

BY Alaric DeArment

ALLEGAN, Mich. Perrigo has filed for regulatory approval of a generic version of an over-the-counter medication for frequent heartburn, prompting a lawsuit from the branded version’s manufacturer.

The company announced Friday that it had filed for approval for omeprazole and sodium bicarbonate in the 20 mg/1,100 mg strength. The medication is a generic version of Zegerid OTC, made by Schering-Plough HealthCare, a subsidiary of Merck.

 

Schering-Plough filed a lawsuit Monday alleging patent infringement in the U.S. District Court for the District of New Jersey to prevent Perrigo’s commercialization of the product.

 

 

Zegerid had sales of around $60 million during the 12-month period ended in the “most recent month,” according to SymphonyIRI Group.

 

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