US Food And Drug Administration Issues Equivalence Guideline For Biosimilars Producers 05/01/2017 by Intellectual Property Watch 1 Comment Biotherapeutic medicines are made out of living organisms and cannot be replicated. No generic medicines, which are exact copies of the reference product, can be made. The generic equivalent of a biotherapeutic would be biosimilars, which are highly similar products. The United States Food and Drug Administration has issued a guide to help producers to prove how close their biosimilars are to the biotherapeutics.
USTR Nominee Lighthizer May Fit Strong Stance On IP Protection 03/01/2017 by William New, Intellectual Property Watch Leave a Comment Robert Lighthizer, President-elect Donald Trump’s newly named choice for United States Trade Representative, appears to fit Trump’s strong stance on China, including on intellectual property protection, but is a longstanding Washington Republican insider and negotiator of trade agreements, which might seem contrary to Trump’s stated questioning of the status quo. Still, some say he is apart from Trump’s other appointments on trade in important ways.
Roundtable: ‘Appropriate Level’ Of Protection Is Key For Impact Of Patents In Health, Innovation 03/01/2017 by Peter Kenny for Intellectual Property Watch Leave a Comment One of the key questions around the impact of patents on health and innovation is what is the appropriate level of protection for companies innovating, says Dr. Marie-Paul Kieny, assistant director-general, Health Systems and Innovation, at the World Health Organization.