Replies to post #110939 on Biotech Values

[hptaxis]

TEVA Citizen Petition - December 2010

FDA’s five criteria for assessing active ingredient sameness with respect to generic LOVENOX were also raised in a December 10th citizen petition submitted on behalf of Teva Neuroscience, Inc. (“Teva”) - http://www.hpm.com/pdf/COPAXONE%20-%203dCP.PDF - concerning FDA’s ability to approve generic versions of the company’s COPAXONE (glatiramer acetate injection), a drug product approved for the reduction of frequency of relapses in relapsing-remitting multiple sclerosis.

[biomaven0]

There's some interesting stuff there.

I would note the following reiterates a point I made previously - the FDA did not require "sameness" or complete characterization in approving MNTA's generic:

ONDQA’s scientists, including FDA’s own expert on heparin and heparin-based products, Dr. Ali Al Hakim, explained that a showing of active ingredient sameness for enoxaparin is impossible without complete characterization of all of enoxaparin’s oligosaccharide chains. ONDQA argued that, because enoxaparin consists of a mixture of oligosaccharides, it cannot be determined which components of the mixture contributed to enoxaparin’s activity. ONDQA further explained that OGD’s five criteria are inadequate to demonstrate sameness and criticized OGD for relying on “inference” to do so. ONDQA asserted that OGD’s proposed methodology was contrary to both the law and FDA policies. [(Internal citations omitted)]

This disagreement was resolved in a July 20, 2010, intra-agency memorandum, according to sanofi, in which Dr. Keith Webber, Deputy Director of the Office of Pharmaceutical Science (and acting OGD Director) determined that the five criteria are a “valid approach . . . for purposes of ANDA approval.” According to sanofi, Dr. Webber “[rejected] ONDQA’s argument that OGD’s approach was inconsistent with FDA policy involving drugs that had not been fully characterized [and] asserted that ‘[d]epending on the kind of drug at issue, there may be different ways to show active ingredient sameness’ and that OGD’s approach was acceptable as applied to enoxaparin.”