Latest News
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1 April 2013
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The US Food and Drug Administration (FDA) has released a fourth and long-anticipated draft guidance document pertaining to the regulatory pathway for biosimilar products, this time on how sponsors
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Latest News
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18 March 2013
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In a speech before the biotechnology industry of Massachusetts, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg explained that her agency is doing all that it can to meet the
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Latest News
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30 January 2013
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A famous quote from Shakespeare famously states that, "A rose by any other name would smell as sweet." But if a recent spat covered in The New York Times on the interchangeability of biological
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Latest News
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9 January 2013
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Manufacturers of pharmaceutical products may be experiencing their best approval rates in years thanks to a more receptive US Food and Drug Administration (FDA), but that doesn’t mean the industry is
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Latest News
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8 October 2012
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A host of biopharmaceutical regulatory issues are said to be at the forefront of trade talks between the US and a group of 11 countries in the Asia-Pacific, potentially complicating both the agreement
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Latest News
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28 September 2012
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The European Medicines Agency (EMA) has announced its intent to accept clinical data from biosimilar medicines approved outside the European Economic Area (EEA), allowing companies an alternate and
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Latest News
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17 September 2012
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A new survey released by the Alliance for Safe Biologic Medicines (ASBM), a group supported by branded biologics companies, says that biosimilar medicines should be required to use distinct names to
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Latest News
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31 July 2012
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The US Food and Drug Administration (FDA) has published information regarding user fees payable to the agency between October 2012 and September 2013 for prescription drug, veterinary and biosimilar
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Regulatory Update
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11 July 2012
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India’s Central Drugs Standard Control Organization (CDSCO) published the final biosimilar guidance setting forth the regulatory requirements for marketing authorization for such products on 4 July
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Regulatory Update
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25 June 2012
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Brazil’s National Health Surveillance Agency (ANVISA) published a new proposed rule on medicines used as reference products for generic equivalents (RDC No. 35/12) on 19 June 2012.According to the
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