The Biotechnology Industry Organization (BIO) has won the latest battle over follow-on biologics. Last week, the House Energy and Commerce Committee approved Rep. Anna Eshoo’s (D-CA) amendment to the America’s Affordable Health Choices Act (H.R. 3200). The Eshoo amendment, a regulatory pathway for the approval of biosimilars, would grant about 12 years of market exclusivity to each new biological medicine.
In a statement released after the vote, BIO’s President Jim Greenwood said the exclusivity period would ensure innovation, presumably because it would provide incentives for investing in biopharmaceutical innovators. Greenwood also remarked that the legislation would help avoid patient and provider “confusion” over biosimilar products. I can’t understand what Greenwood means by that, unless he takes “confusion” to mean “choice.”
The Generic Pharmaceutical Association (GPhA) also weighed in last week, expressing its disappointment in the House Committee. The Eshoo bill would delay the introduction of affordable medicines, said GPhA President and CEO Kathleen Jaeger in a statement released last week. H.R. 3200 does not include a “reasonable and proven successful period of market exclusivity,” Jaeger said, alluding to the Waxman amendment.
President Obama had reiterated his support for a seven-year exclusivity period for biopharmaceuticals two days before the Committee vote. Party loyalty apparently did not influence the Committee members’ deliberations. The shape of the bill that will end up on Obama’s desk remains to be seen, but BIO can claim an important victory for the moment.