Biotech Values

[DewDiligence]

Generic biologics are coming:

[In reply to the latest posts by Biowatch and Kakie on the PPHM board: #msg-2379622]

Generic biologics are coming, but they might not be the kinds of generics we are accustomed to.

The kinds of generic biologics I expect to see are ones brought to market under section 505(b)(2) of the Hatch-Waxman Act, which allows the maker of a compound that it substantially similar (although not identical) to an approved drug to use the approved drug’s clinical data to support an FDA application.

Using this approach, the maker of a generic biologic will need to run only a few, relatively small trials to show safety, efficacy, and near bioequivalence --rather than the full panoply of trials ordinarily needed for FDA approval.

A generic biologic brought to market under section 505(b)(2) won’t be substitutable at the pharmacy for the drug to which it is similar; hence such a drug will need to be actively marketed. However, the ability to utilize the clinical data of the similar drug will greatly reduce the overall expenses of the clinical-development program. These lower costs combined with the competitive pressures of having multiple similar drugs will reduce the prices consumers will pay for biologic drugs. And that’s the whole point of having generics, isn’t it?