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Competition for 505(b)(2) Approvals

Yesterday I presented an audioconference on 505(b)(2) candidate selection. A participant posed the following question:

What if our company is developing a drug product (A) and a competitor is also developing a similar product (A’). Can both be approved?

The way this would normally work at FDA is that it would approve the first product that is approvable. When the second product becomes approvable the Agency will make a determination of how similar A and A’ are. If, in their judgment, the 2 products are ‘similar’ then the first approved product becomes the RLD to the second product and the second product goes back to a phase 1 bridging study. On the other hand, if FDA decides that A and A’ are different, then both are approved. There is no written standard on what constitutes ‘similar’, though it appears to be broader than similarity under 505j ANDA’s.

Camargo has been involved in 2 of these ‘races’ to the finish line. Using publically available information we were able to assure that the products were ‘different’, thus avoiding a conflict.