PHARMACY

GPhA responds to Pathway for Biosimilars Act

BY Alaric DeArment

ARLINGTON, Va. While drawing applause from the Biotechnology Industry Organization, a second bill to allow a regulatory pathway for biosimilars has met opposition from the organization representing the generic drug industry.

The Generic Pharmaceutical Association released a statement Tuesday criticizing H.R. 1548, the Pathway for Biosimilars Act, introduced by Rep. Anna Eshoo, D-Calif., and others.

“The Pathway for Biosimilars Act is the wrong road for patients looking for safe and affordable biogeneric medicines, particularly during these difficult economic times,” GPhA president and CEO Kathleen Jaeger stated. “It is a long route filled with needless roadblocks that will keep patients from getting needed medicines in a timely manner.”

The GPhA supported a previous bill, the Promoting Innovation and Access to Lifesaving Medicine Act, introduced earlier this month by Rep. Henry Waxman, D-Calif., and others. The Waxman bill provided for five years of market exclusivity before biotech drugs face biosimilar competition, much as the Hatch-Waxman Act of 1984 provides for pharmaceutical drugs. By contrast, Eshoo’s bill provides for 12 years of exclusivity, a much longer period, but still short of the 14 years that BIO wants.

“Given that there is a minimal difference of less than eight months longer in the development of biopharmaceuticals when compared to traditional pharmaceuticals, there is little justification for excessively expanding exclusivity beyond the Hatch-Waxman model,” Jaeger said. “Excessive exclusivity means that it will be decades before patients have access to affordable biogeneric medicines.”

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Congress introduces new biosimilars bill

BY Alaric DeArment

WASHINGTON Members of Congress have introduced a second biosimilars bill to compete with the one introduced earlier this month by Democratic Rep. Henry Waxman of California and others.

Reps. Anna Eshoo, D-Calif., Jay Inslee, D-Wash., and Joe Barton, R-Texas, introduced H.R. 1548, the Pathway for Biosimilars Act Tuesday afternoon. The Biotechnology Industry Organization had announced Monday that it expected the bill’s introduction.

While the Waxman bill, the Promoting Innovation and Access to Life-Saving Medicine Act, provides for a five-year market exclusivity period for branded biotech drugs, Eshoo’s bill provides for 12 years of exclusivity.

BIO, which favors an exclusivity period of 14 years, opposed the Waxman bill, describing it as “filled with potholes,” but expressed support for the Eshoo bill.

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Pfizer granted patent renewal for Lipitor

BY Allison Cerra

NEW YORK Pfizer announced Tuesday that the U.S. Patent and Trademark Office has granted reissue patent RE40667, relating to Lipitor.

The company had applied for the reissue patent in January 2007, in order to correct a technical defect in the ‘995 enantiomer patent for atorvastatin calcium, the salt form of atorvastatin sold as Lipitor.

On Jan. 6, the company announced that the U.S. Patent & Trademark Office had issued a “Notice of Allowance” accepting the company’s application to correct the technical defect in the ‘995 patent.

The reissue patent will have the same force and effect as the original ‘995 patent and the same June 2011 expiration date (including the six-month pediatric exclusivity period).

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