![]() The discussion quickly evolved into a fascinating discussion of therapeutic equivalence. Typically, parenteral or ophthalmic products may use an exception excipient in its formulation to avoid a patent issue and, because of regulatory restriction on what formulation differences can be made to these types of products, make the changed product ineligible for submission under 505(j) (as a generic). The Complex Generic 505(j) v 505(b)(2) forum discussed the use of the (b)(2) process for products that differ in some aspect from the RLD. Note that biosimilar products are not constrained by device differences or label sameness like ANDAs. Panel members also provided suggestions for FDA to include some examples of issues associated with human factor studies especially in the realm of virtual studies that may be required because of COVID or lack of patients or volunteers. FDA’s advice was that if there are any differences in design or labeling proposed, that the firm either use a controlled correspondence or pre-ANDA meeting to get resolution prior to final development and well in advance of submission of the ANDA. The advice from the panel was that the products must be the same and not better, but minor changes in labeling can be made under the permissible changes because the product is made by a different manufacturer, but those differences are limited. There were discussions about labeling differences and one questions raised by the audience asked if a change in labeling or the device to make it easier to use the product would be acceptable. Minor changes may be permitted but the bottom line with a critical design element change is that “FDA expects that end users of generic combination products, including but not limited to lay-persons, such as patients, and/or caregivers, can use the generic combination product when it is substituted for the RLD without the intervention of the health care provider and/or without additional training prior to use of the generic.” If such training or education is needed to support the change, then the change would likely not be permitted in an ANDA. The issues associated with the critical design elements that differ from the reference listed drug (RLD) could constitute important differences that could preclude the submission or approval of the change in an ANDA. The combination product similarity session described the various permutations of the sameness requirements for devices when part of a drug product. 505(b)(2) and the other on Generic Drug Case Law. ![]() ![]() The afternoon sessions of the conference that I was able to attend included a discussion of Combination Products and Similarity, and two legal-based sessions, one on Approval Pathways for Complex Generics – 505(j) vs.
0 Comments
Leave a Reply. |