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    Comparison of Data Requirements for the Approval of a Biosimilar Versus the Reference Medicine

    This article compares and contrasts several aspects of biological products versus biosimilar products. The author defines both biologics and biosimilars and explains how and why the two differ in terms of their organic natures. She also guides the reader through the biologic vs. biosimilar developmental and testing stages and through agency approval and postmarketing surveillance. The author clarifies important points to consider when developing biologic and biosimilar pro...
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    How I Returned to Regulatory Affairs After a 10-Year Break

    The decision whether or not to take a career break can be an agonizing one. You might be thinking about stepping away to raise a family, care for an ailing relative, take a sabbatical, because of redundancy or for a number of other reasons. Whatever the reason, many consider it to be professional suicide. It doesn’t have to be. I was able to make a successful return to the world of regulatory affairs after a 10-year career break. That’s not to say it’s easy. There are m...