I am still contemplating the copaxone "sameness" issue, and have not had time to type up my thoughts. Nevertheless, I found the court's ruling and document on the enoxaparin situation in which U.S. District Judge Sullivan refused to issue a preliminary injunction following Sanofi's request to block enoxaparin.
ecf.dcd.uscourts.gov
I found the entire document and particularly the part copied below to be especially relevant to the copaxone situation, thus I am parking it here. (Sorry that the spacing in the exerpt below is screwed up but I have not patience to fix that.)
BJ
"Finally, Sanofi argues that it is likely to succeed on the
merits because the FDA approved generic enoxaparin without sufficient evidence that Sandoz’s ANDA has the “same” active
ingredient as Lovenox as required by § 355(j)(2)(A). Sanofi
contends that in approving Sandoz’s ANDA, the FDA “ignored
voluminous scientific evidence demonstrating that until
enoxaparin is fully characterized, generic enoxaparin products
that do not use a manufacturing process that is equivalent to
[Sanofi’s] process will not be the same as Lovenox.” Pl.’s Mem.
at 33. It further asserts that the FDA failed to provide a
“rational explanation for its decision to disregard scientific
evidence that directly contradicts its administrative findings,” and therefore is arbitrary and capricious. Pl.’s Mem. at 33-34. The Court finds these arguments unavailing.
In its response to Sanofi’s citizen petition, the FDA
provided a detailed explanation regarding its determination that an ANDA applicant for enoxaparin can demonstrate “active
ingredient sameness” by meeting five criteria, “each of which
captures different aspects of the active ingredient’s
‘sameness.’ AR 2879-80. In particular, the FDA found that an ANDA applicant seeking approval for generic enoxaparin must
demonstrate: (1) equivalence of physicochemical properties, such as molecular weight distribution and overall chemical
composition; (2) equivalence of heparin source material (i.e.,
heparin that is derived from porcine intestinal mucosa and that
meets USP monograph standards for Heparin Sodium USP) and mode of 25 depolymerization (i.e., cleavage by alkaline ß-elimination of the benzyl ester derivative of heparin); (3) equivalence in disaccharide building blocks, fragment mapping, and sequence of oligosaccharide species; (4) equivalence of in vitro biological and biochemical assay results; and (5) equivalence of in vivo pharmacodynamic profile based upon measurements of in vivo anti- Xa and anti-IIa profiles. See AR 2888-900.”
The FDA also provided an exhaustive response to the arguments raised in Sanofi’s citizen petition, see generally AR 2904-21, including Sanofi’s claim that the FDA should refrain from approving any ANDAs citing Lovenox as the RLD unless, among other things, the manufacturing process used to create the generic drug product was deemed to be equivalent to Sanofi’s manufacturing process for Lovenox. See AR 2905-13 (explaining why ANDA applicants for enoxaparin do not need to demonstrate that they use the same manufacturing process as Sanofi)." |
