Regulators in the USA have received another citizen petition from Teva Pharmaceutical Industries questioning the criteria for assessing generic versions of its multiple sclerosis blockbuster Copaxone.
The Israeli firm is asking the US Food and Drug Administration to refuse to approve any abbreviated New Drug Application for a“purported generic version” of Copaxone (glatiramer acetate) based primarily on “the inability to establish acceptable ‘sameness’ of the active ingredients”. Teva says its request should be upheld due to “the complexity of the mechanism of action of a glatiramoid and the inapplicability of leveraging conventional pharmacokinetic and pharmacodynamic testing methods to demonstrate bioequivalence”................... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid=1903