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The primary focus of the FDA, industry, and counsel preparing for the advent of follow-on biologics in the United States has been the legal and regulatory framework governing the approval of such products as biosimilars under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).  However, the BPCIA further provides that the FDA may determine that a biologic product is also interchangeable with (and thus, under Federal law, freely substitutable for) its reference product.  As stakeholders anticipate the potential for “generic biologics,” the FDA has released a draft guidance outlining considerations for applicants seeking to demonstrate interchangeability.  This draft guidance sheds some light on the burdens sponsors of proposed interchangeable biological products (“interchangeables”) will (and will not) face along the path to interchangeable licensure.

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Ha Kung Wong has extensive experience litigating a wide variety of pharmaceutical cases, including those concerning biologics used to treat rheumatoid arthritis and autoimmune disorders. He also has extensive experience consulting, conducting due diligence and licensing pharmaceutical portfolios. Ha Kung has a B.S. in Biochemistry and a B.S. in Chemistry.
Sean McDonagh has experience litigating and prosecuting biologics, biotechnology and pharmaceutical patents. Sean has a B.S. in Human Biology, and an M.S. in Physiology. His graduate work focused on the neurophysiology of the glucagon-like peptide hormones and was published in the American Journal of Physiology.

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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