June 27, 2007 / 5:11 PM / 13 years ago

Teva Pharm comments on the Biologics Price Competition and Innovation Act of 2007

Co notes today, the Senate Health, Education, Labor and Pensions committee will take a significant step forward to ensure that the FDA has the regulatory pathway necessary to establish an approval process for generic biologics. “... The bill will create a scientifically-rigorous, efficient, FDA-driven pathway for both biosimilar and biogeneric products and include a mechanism intended for timely resolution of patent disputes. Unfortunately, there are two critical issues that undermine the promise of the bill for consumers, payers and employers who continue to face increasing health care costs. The first issue is the unprecedented twelve years of market exclusivity the bill provides to the innovator company for developing a compound. Teva, as a significant patent holder, supports strong incentives for innovation, however, twelve years of market exclusivity is four years beyond any other nation and seven years beyond the exclusivity period guaranteed for chemical drugs. Our hope is that the Congress will adopt a more constructive and balanced market exclusivity period that is closer to the Hatch Waxman Act. ..”

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