/publications/issue/2007/2007-07/2007-07-6624

GPhA COOKS UP RECIPE FOR BIODRUG PATHWAY LEGISLATION

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The Generic Pharmaceutical Association's (GPhA) recipe for a streamlined system governing FDA approvals of biosimilars includes several critical ingredients outlined by the group during recent congressional hearings on the issue.

For starters, GPhA contends that the legislation should provide for an approval pathway at the FDA that does not impose unnecessary barriers to prompt market entry. Specfically, GPhA wants ground rules that establish clearly defined comparability criteria for biosimilars and give the FDA discretion to require the needed tests to make safety and effectiveness determinations.

Additionally, the generic industry group has asked for legislative language spelling out the contents of an abbreviated biologic application, setting forth the circumstances under which the FDA can deny approval and ensuring generic manufacturers the ability to obtain an interchangeability rating that is immediately operative.

The approach favored by GPhA would establish no unique names for generic biologics, a provision that the group called "fully consistent with the FDA's position that unique biologic names should not be used to differentiate products with the same active ingredient(s) when credible scientific data demonstrate that no pharmacologically relevant differences exist."

The association is also seeking a timely review process for biosimilars and an approval system that gives the FDA flexibility as to what should be required on the label. "Equally as important, effective biologics legislation must not include provisions?that would unnecessarily delay approval and/or prevent consumers from receiving the biggest benefit from generic biological products," GPhA told Congress.