Biotech Values

[mouton29]

It seems to me that the prohibition against requiring testing is intended to benefit the applicant (who cannot be required to provide study data) and NOT to promote monopoly pricing of the branded

This may be correct. However, not surprisingly, the FDA did not make this argument, since of course the FDA believes it has the authority to both consider and require the testing. But Sandoz did not make your argument either, but they did make a related, but more technical argument. I am curious what others think of this since it relates to the fully substitutable finding that has been discussed many times here.

Sandoz argued:

Sanofi-aventis argues that because of the allegedly improper impurity studies, Sandoz’ ANDA for enoxaparin should have been filed as a New Drug Application under section 505(b) of the FDCA. (Pl’s Mem. at 16, 23-24.) Sanofi-aventis is wrong: the Sandoz ANDA was properly evaluated under section 505(j), for the reasons discussed above and in the FDA’s memorandum. (See FDA Mem. at 25-27.) But if sanofi-aventis was correct that FDA should have considered Sandoz’ application under section 505(b), sanofi-aventis still cannot prevail.

Page 29 of 36
Sanofi-aventis argues that drugs approved under section 505(b) cannot be deemed as therapeutically equivalent to, and therefore are not substitutable for, the referenced brand drug. (See Pl’s Mem. at 16.) Sanofi-aventis is wrong in making this distinction between sections 505(b) and 505(j). In fact, according to FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the “Orange Book,” a therapeutic equivalence rating is available for any FDA-approved drug product so long as it has made the necessary showing. Thus, the criteria by which FDA may assign therapeutic equivalence clearly does not depend on the regulatory pathway chosen, but rather on scientific determinations of equivalence that FDA can make. In this case, FDA has already determined that, as a matter of science and law, Sandoz’ enoxoparin product is therapeutically equivalent to Lovenox and meets all other applicable regulatory requirements.
Therefore, under the law and under FDA’s scientific decision, even if Sandoz had filed a 505(b) application, its application would have been approved, and it would have been awarded therapeutic equivalence because it would have demonstrated therapeutic equivalence.

SNY countered with:

Sandoz asserts that FDA’s approval should not be enjoined because “even if Sandoz had filed a 505(b) application, its application would have been approved and would have been awarded therapeutic equivalence.” Sandoz Br. at 22-23 (emphasis added). Although sanofi disagrees with Sandoz’s views on the applicability of therapeutic equivalence ratings to 505(b)(2) applications, this determination is, of course, not one for Sandoz to make. FDA, moreover, takes a different position in its brief, noting that “approval of any competitor by the [505(b)(2)] pathway ... could result in a non-substitutable – and less competitive – drug product.” FDA Br. at 26 n.13.

The more complete quote in the FDA footnote 13 was:

13 Sanofi does not hide its self-interest motivating its preference for approval of any competitor by the 21 U.S.C. § 355(b)(2) pathway, which could result in a non-substitutable – and less competitive – generic product. Mem. at 30 (urging “that the resulting products should not be substitutable”).

The FDA seems only to be saying that that the 505(b)(2) pathway COULD result in a nonsubstitutable approval, not that it would have in this case, where they also found the generic was identical to the reference drug.