Armstrong Quoted On Bills To Bring Follow-On Biologics to MarketSpecialty Pharmacy News April 23, 2009
Mark Armstrong, a Member of the Firm in the Health Care and Life Sciences practice of Epstein Becker Green Wickliff & Hall in Houston, was quoted in an article titled, "New Bills Introduced in Congress Renew Effort to Bring Follow-on Biologics to U.S. Market."
The push to create a pathway to bring biosimilars to the U.S. market has begun in the 110th Congress, the article reported, with the introduction of a handful of bills and at least one more expected.
Among the key bills is H.R. 1427, known as the Promoting Innovation and Access to Life-Saving Medicine Act, introduced by Reps. Henry Waxman (D-Calif.), Frank Pallone (D-N.J.), Nathan Deal (R-Ga.) and Jo Ann Emerson (R-Mo.).
Among the issues raised by the Waxman bill and others, the most important is exclusivity, said Armstrong. The Waxman bill allows innovator products that are approved after the legislation is enacted to have five years of data exclusivity, with an additional three years possible, plus another six months for pediatric exclusivity and another six months for a significant therapeutic advance.
"The exclusivity period is most significant," Armstrong said, adding that biologics manufacturers will push for a period of more than five years. And while the generic pharmaceutical industry will certainly argue for a shorter period, "consumers will really drive" the issue, he said. "The representatives and senators will be voting with their constituents in mind."