• Feature ArticlesFeature Articles

    Nitrosamine impurities: Regulatory action in the US, EU, and Canada

    The identification of nitrosamine impurities in some drug products has prompted manufacturers to recall the products over concerns about the carcinogenic properties of nitrosamines. Agencies and manufacturers are evaluating the risks and chemistry of the drug products to find a solution to the contamination.   Introduction Valsartan (Diovan) is an important first-line therapy for hypertension and congestive heart failure. It also lowers the risk of death after myoc...
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    Regulatory Progress of Biosimilars: An Update

    This article discusses issues related to the development and marketing of biosimilars aimed at having the same therapeutic effects as biotherapeutics. The author covers biosimilar approvals in Europe and the US, comparability studies, labeling issues, interchangeability and postmarketing issues. Over the last 10 years, biosimilar acceptance has progressed significantly both in the EU and US, although the author notes several organizations advocating for more complete, acc...