Adding Follow-On Biologics to PDUFA Legislation ‘Unlikely,’ BIO CEO Says

It is “very unlikely” legislation creating an approval pathway for follow-on biologics will be included in the FDA Revitalization Act (FDARA), Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood said.

The two versions of the bills, S. 1082 and H.R. 2900, are currently pending before a conference committee. The Senate version of the bill contains a placeholder for follow-on biologics legislation, but the House has not yet discussed the issue, Greenwood said in a meeting with reporters. House Energy and Commerce Committee Chairman John Dingell (D-Mich.) would “oppose strenuously” having the bill added before House discussions, he added.

However, Rep. Frank Pallone (D-N.J.) said separately at the Generic Pharmaceutical Association’s (GPhA) Annual Policy Conference that he would try to get follow-on language inserted in FDARA, although he acknowledged that its passage as part of the bill was unlikely.

Greenwood, a former Republican congressman from Pennsylvania, said he heard that Congress is aiming to pass a final version of the bill by Sept. 21. At the GPhA conference, Pallone said congressional staffers were currently meeting and trying to come to an agreement on a conference report.

The Senate Health, Education, Labor and Pensions Committee passed the Biologics Price Competition and Innovation Act, S. 1695, by unanimous voice vote earlier this summer, establishing a way for the FDA to approve products as biosimilar to existing biologics.

S. 1695 would grant 12 years of data exclusivity to innovator biologic drugs, but BIO wants 14 years of exclusivity, Greenwood said. The bill needs an appropriate period of data exclusivity to maintain the balance between innovators and generic companies, he added.