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Senate panel backs 12 years market exclusivity for biotech drugs; industry responds


WASHINGTON Biotech drugs could receive protection from competition by cheaper, follow-on versions for more than twice as long as branded pharmaceutical drugs under a plan approved by a Senate committee Monday night.

The Senate Health, Education, Labor and Pensions Committee voted 16-7 in favor of a plan to allow 12 years of market exclusivity for biotech drugs before they face biosimilar competition. That’s two years short of the biotech industry’s preferred 14 years, but more than the five years favored by the generic drug industry and groups like the Pharmaceutical Care Management Association and the seven years desired by the Obama administration and AARP.

Senators voting in favor of the plan included Orrin Hatch, R-Utah, who lent his name to the original Hatch-Waxman Act of 1984, which cleared the way for generic pharmaceutical drugs.

The other sponsor of the 1984 bill, Rep. Henry Waxman, D-Calif., has introduced a bill in the House that would allow five years of market exclusivity for biologics and has racked up 13 cosponsors since its introduction in March. By contrast, a competing bill introduced by Rep. Anna Eshoo, D-Calif., that would allow 12 to 14 years of market exclusivity, has 131. Waxman’s bill also has a companion in the Senate, introduced by New York Democrat Charles Schumer, with seven cosponsors, but the HELP Committee’s vote and Eshoo’s bill place proponents of longer exclusivity periods well ahead.

The Generic Pharmaceutical Association criticized the vote, while the Biotechnology Industry Organization heralded it.

“While we are extremely disappointed that the committee action could result in patients having little or no access to affordable biogenerics, we will continue to fight in the House to ensure that a true balance is achieved between innovation and competition,” GPhA president and CEO Kathleen Jaeger said. “It is surprising that in the wake of the recent Federal Trade Commission report explicitly stating that 12 years of exclusivity would discourage innovation, the HELP Committee voted in favor of profits over patients.”

While it has uncompromisingly pushed for 14-year exclusivity periods, BIO nevertheless welcomed the committee’s decision.

“Last night’s vote is a victory for the patients of today and tomorrow who are living with debilitating diseases including cancer, HIV/AIDS, Parkinson’s and a host of rare diseases,” BIO president and CEO Jim Greenwood said. “The HELP Committee has taken a critical step forward on the path toward biosimilars. The approved language strikes the appropriate balance among ensuring patient safety, expanding competition, reducing costs and providing necessary and fair incentives that will provide for continued biomedical breakthroughs.”

The PCMA, which represents the country’s pharmacy benefit managers, expressed disappointment, but remained optimistic.

“Despite this setback, the biogenerics debate marches on and is a bellwether for Washington’s capacity for real health reform,” PCMA president and CEO Mark Merritt said. “Either Congress will side with the voters who expect real change — the seniors, consumers, employers and unions who support meaningful biogenerics reform — or it will let health costs continue to soar as a courtesy to special interests.”

Note: The bill was passed as an amendment to the healthcare reform bill that passed days later, an aide to Sen. Mike Enzi, R-Wyo., told Drug Store News.

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