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Under the Consent Decree, after receiving notice from the FDA of being in compliance with applicable laws and regulations, each of the three facilities is subject to a five-year audit period by a third-party cGMP expert.

At some point in the process, it will also be important for both the innovators and the developers of biosimilars to determine which analytical methods are appropriate for inclusion with regulatory filings, and to what degree these analytical measurements contribute to assessing physicochemical stability and clinical relevance, especially given the concerns stemming from adverse clinical events involving biopharmaceuticals (see the 27 October 2010 press release on the FDA website) and the vexing problem of assessing comparability in relation to immunogenicity.

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This equity account includes the results of translating certain balance sheet assets and liabilities at current exchange rates and some accounts at historical rates, except for those located in highly inflationary economies.

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