505(b)(2): A Pathway to Competitiveness Through Innovation for Specialty and Generic Companies

Pharmaceutical Executive

As the market for specialty and generic products continues to become more competitive and pricing pressures increase, the 505(b)(2) pathway may offer an attractive alternative for companies looking to differentiate their products and diversify their portfolios.

Section 505(b)(2) expressly permits FDA to rely on data not developed by the applicant to be considered for the registration of drug products. Generally, the sponsor is seeking a change to the product label claims (which must be supported with new data from appropriate studies) from the previously-approved product.

Approvals for 505(b)(2)s, which build upon and provide differentiation from previously approved products, has risen in recent years. In fact, FDA approved 313 such products from 2013 to 2018—comprising 50% of all NDA approvals. In this article, we analyze submissions, approvals, and sales trends during this time period to help companies more fully evaluate the 505(b)(2) pathway potential and identify areas of opportunity.

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