PHARMACY

Sen. Schumer introduces companion bill to biosimilars legislation, receives mixed response

BY Alaric DeArment

NEW YORK Sen. Charles Schumer, D-N.Y., introduced a bill in the Senate Thursday as a companion to legislation introduced earlier this month by Democratic California Rep. Henry Waxman to allow a regulatory pathway for biosimilars.

The bill, which shares the House bill’s title, the “Promoting Innovation and Access to Life-Saving Medicine Act,” has drawn applause from the Generic Pharmaceutical Association, while the Biotechnology Industry Organization has criticized it.

“Momentum is skyrocketing for biogenerics legislation that puts patients and pharmaceutical innovation first,” GPhA president and CEO Kathleen Jaeger stated. “The legislation introduced [Thursday] in the Senate and last week in the House demonstrates that lifesaving biogenerics can get to patients in need sooner rather than later while also fostering competition to drive pharmaceutical innovation.”

Co-sponsors included Sens. Sherrod Brown, D-Ohio, Susan Collins, R-Maine, Mel Martinez, R-Fla., Jeanne Shaheen, D-N.H., Debbie Stabenow, D-Mich., and David Vitter, R-La.

In its own statement Thursday, BIO said the bill “takes shortcuts.”

“While well-intentioned, the bill introduced [Thursday] by Sens. Schumer, Brown, Collins and Martinez follows its companion bill in the House through the looking glass to a world of biosimilars that would jeopardize patient safety and undermine future medical breakthroughs,” BIO president and CEO Jim Greenwood said. “The legislation shortcuts scientific requirements needed to ensure patient safety and creates an imbalanced system that could chill investment in research focused on discovering new treatments and cures for devastating diseases, such as cancer, Alzheimer’s, Parkinson’s and multiple sclerosis.”

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Two new diabetes drugs to be reviewed by FDA next week

BY Alaric DeArment

NEW YORK The Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee will review two new diabetes drugs next week, and this has left investors nervous, according to published reports.

On April 1, the committee will review Onglyza (saxagliptin), by AstraZeneca and Bristol-Myers Squibb, and review Victoza (liraglutide) the next day. According to Reuters, however, an FDA rejection earlier this month of Takeda Pharmaceutical’s alogliptin calling for additional clinical data, caused the company’s stock to fall.

According to the news agency, an analyst said that the FDA might be slow to approve drugs similar to those on the market. Onglyza is a DPP-4 inhibitor, belonging to the same class as alogliptin; Merck & Co.’s DPP-4 inhibitor Januvia (sitagliptin) is already on the market.

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Mylan confirms first-to-file challenges

BY Alaric DeArment

PITTSBURGH Mylan could get exclusive rights to four generic drugs.

The generic drug maker confirmed Thursday that six drug companies and two research centers had sued it in connection with four “first-to-file” regulatory approval applications containing Paragraph IV certifications.

  • Sepracor sued Mylan and Alphapharm in the U.S. District Court of New Jersey over an application for eszopiclone tablets in the 1 mg, 2 mg and 3 mg strengths. The tablets are a generic version of the insomnia drug Lunesta, which had sales of $796 million in 2008, according to IMS Health.
  • Shire sued Mylan and subsidiary Matrix Labs in the U.S. District Court for the Southern District of New York over an application for lanthanum carbonate chewable tablets in the 500 mg, 750 mg and 1 g strengths. The tablets, used to treat kidney disease, are a generic version of Fosrenol, which had sales of $108 million in 2008, according to IMS Health.
  • OSI Pharmaceuticals, Pfizer and Genentech sued Mylan in the U.S. District Court in Delaware over an application for erlotinib hydrochloride tablets in the 25 mg, 100 mg and 150 mg strengths. The tablets, used to treat lung cancer, are a generic version of Tarceva, which had sales of $492 million in 2008, according to IMS Health.
  • Galderma Labs, New York University and the Research Foundation of the State University of New York sued Mylan in the U.S. District Court of Delaware over an application for doxycycline delayed-release capsules in the 40 mg strength. The capsules are a generic version of Galderma’s adult rosacea treatment Oracea, which had sales of $82 million in 2008, according to IMS Health.

Under the Hatch-Waxman Act of 1984, the first company to seek approval for a generic version of a drug gets six months of market exclusivity once the generic drug gets final approval from the Food and Drug Administration. A Paragraph IV certification asserts that a branded company’s patent on a drug is invalid, unenforceable or won’t be infringed by a generic version.

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