The quest for generic biotechnology pharmaceuticals in the USA
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Keywords: generic biologics, biogenerics, biotechnological pharmaceuticals, follow-on biologics
Thomas J. Kowalski Frommer Lawrence & Haug, LLP, 745 Fifth Avenue, New York, NY 10151, USA Tel: +1 212 588 0800 E-mail: [email protected]
The quest for generic biotechnology pharmaceuticals in the USA Thomas J. Kowalski, Pamela Fekete and Anne-Marie C. Yvon Date received (in revised form): 10th December, 2004
Abstract As patent protection expires on the first generation of biotechnology products, such as human growth hormone and erythropoietin, there is an impetus for the development and marketing of generic equivalents. Currently there is no statutory or regulatory framework governing generic biotechnology products. This paper explores the potential solutions that have been suggested by members of the pharmaceutical industry and government, both in the USA and internationally.
In the USA, a company can bring a generic version of a certain pharmaceutical product to market either when the product loses patent protection, such as by expiration or invalidation by a court ruling, or under the Hatch– Waxman Act. The Act provides a mechanism for companies to file a New Drug Application under Section 505(b)(2), relying on safety and efficacy studies not performed by or for the applicant (referred to in this context as a ‘paper NDA’), or an Abbreviated New Drug Application (ANDA) under Section 505(j). As first generation biotechnology products are approaching the loss of patent protection, many companies are interested in marketing competitive versions of these products. There is currently no established statutory or regulatory scheme for effecting this result. While the Food and Drug Administration (FDA) has indicated that the 505(b)(2) route might be available for this purpose,1 it recently indicated in a response to several citizen petitions regarding 505(b)(2) that it will specifically address the use of 505(b)(2) for biologic-type products at some future time.2 Therefore, unlike traditional pharmaceutical products, for which a steady stream of generics have been reaching the market in a pattern that directly correlates with
patent expiry, the path to ‘biogenerics’ is less straightforward. Even the terminology used to describe biotechnological and biological products is unsettled. ‘Biological products’ are regulated under the Public Health Service Act (42 USC §262) and defined as a ‘virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.’3 This definition does not appear to include biotechnological products, such as recombinant insulin and human growth hormone. (Even if it did, however, there is no provision in the Federal Biologics Act for an abbreviated application process.) The terms ‘biogenerics’ and ‘follow-on biologics’ have been suggested for generic
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