GPhA Urges FDA to Create Abbreviated Follow-On Pathway

On the heels of a recent workshop on follow-on biologics, the Generic Pharmaceutical Association (GPhA) is again encouraging the FDA to create an abbreviated approval pathway for generic biologics.

"Today, the question is not 'if' generic biopharmaceuticals will become a reality, it is 'how,'" Gordon Johnston, vice president of regulatory affairs for GPhA, said in closing remarks at the FDA/Drug Information Association Follow-On Protein Pharmaceuticals Workshop.

While GPhA praised the FDA on the progress made at the meeting, it urged the agency to proceed more quickly on generic biologics, which it said are well "within the scope of current science."

"There is no reason to delay consumer access to affordable medicines when sound science supports the approval of biopharmaceuticals under a shortened and less costly pathway," GPhA President and CEO Kathleen Jaeger said during the workshop. "It is possible to permit approval and marketing of a vast array of biopharmacuticals with relatively low to modest complexity, and to expand that system in the coming years to permit the approval of more complex products."

Jaeger urged the FDA to issue its highly anticipated white paper and guidance document on follow-on biologics immediately. According to GPhA, the FDA announced four years ago that it would be working on guidelines for insulin and human growth hormone, but the agency has not yet released this information.