Fierce Pharma has published a copy of a citizen petition filed by Sandoz that challenges the FDA’s recommendations for establishing bioequivalence for generic copies of Advair Diskus 100/50. The FDA published the draft guidance for fluticasone propionate/salmeterol xinafoate in September 2013.
The Sandoz citizen petition, submitted October 13, 2016, contends that the PK BE study recommendations in the draft guidance fail to take Advair Diskus 100/50 batch-to-batch variability and short Tmax values into account, and therefore the FDA should not approve any ANDAs that rely on those recommendations.
According to the petition, “Sandoz’s data demonstrate that FDA’s PK study recommendations, if followed, could result in inaccurate bioequivalence conclusions.” Sandoz acquired Oriel Therapeutics and its generic Advair development program in 2010.
Specifically, the petition says that the FDA should not approve any ANDAs for Advair generics unless:
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“(1)Type I error rate is adequately controlled in PK bioequivalence testing, including accounting for Type I error rate inflation caused by batch-to-batch variability of the RLD;
(2) the dose used in PK bioequivalence testing retains the necessary sensitivity to product differences existing at the marketed single inhalation dose of the RLD; and
(3) the sampling schedule used in PK bioequivalence testing is robust and centered around the actual time to maximum plasma concentration of both active ingredients at the marketed dose of the RLD.”
In it’s conclusion, the petition reiterates that “these issues could result in patient-relevant and recognizable differences among AB-rated generics” and that the FDA should not approve any generics before addressing the PK issues. Sandoz adds, “As with all OIDPs, FDA must aim to approve high quality products that satisfy not only the need for public access, but also public confidence.”
Read the Sandoz citizen petition.
Read the FDA draft guidance.
Read the Fierce Pharma article.
