My read is that they just need to show equivalence to Taxol, since it is considered a modification to a previously approved drug. But I am unsure what it means in practical terms. Will their trials be smaller or less costly?
For changes to a previously approved drug product, an application may rely on the Agency's finding of safety and effectiveness of the previously approved product, coupled with the information needed to support the change from the approved product. The additional information could be new studies conducted by the applicant or published data. This use of section 505(b)(2), described in the regulations at 21 CFR 314.54, was intended to encourage innovation without creating duplicate work and reflects the same principle as the 505(j) application: it is wasteful and unnecessary to carry out studies to demonstrate what is already known about a drug. The approach was described in a letter to industry dated April 10, 1987, from Dr. Paul D. Parkman, then Acting Director of the Center for Drugs and Biologics. This guidance helps to clarify and amplify the approaches stated in the April 10, 1987, letter and in the regulations.
An applicant should file a 505(b)(2) application if it is seeking approval of a change to an approved drug that would not be permitted under section 505(j), because approval will require the review of clinical data. However, section 505(b)(2) applications should not be submitted for duplicates of approved products that are eligible for approval under 505(j) (see 21 CFR 314.101(d)(9)).
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