An Overview of the Scientific and Regulatory Issues Facing Biogenerics in the USA Today

Anon (2004) ‘Strategies for Biogeneric Success’, Bridgehead International Limited, June, p. 1. Available at http://www.the-infoshop.com/study/bdg21413_biogeneric.html.

Polastro E. T. (2001) ‘The Future of Biogenerics’, Contract Pharma, 13th October, p. 1. Available at http://www.contractpharma.com/Oct013.htm.

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Polastro E. T. (2001) ‘The Future of Biogenerics’, Contract Pharma, 13th October, pp. 4–5. Available at http://www.contractpharma.com/Oct013.htm.

Sicor Pharmaceuticals, Inc. (2004) Presentations by Art LeBlanc and Suzanne Sensabaugh at the FDA Public Workshop, Rockville, MD, 14th September.

Anon (2004) ‘FDA punts on Sandoz's follow-on biologic’, Generic Line, 8th September, p. 6.

Polastro E. T. Tulcinsky S. (2004) ‘Are biopharmaceuticals immune to the generics threat?’, Journal of Generic Medicines, Vol. 1, No. 3, pp. 259–265.

Anon (2001) ‘The challenge of producing generic biopharmaceuticals’, IMS Health, 11th May, p. 2. Available at http://www.ims-global.com/insight/news_story/0106/news_story_010612.htm.

Anon (2004) ‘Strategies for biogeneric success’, Bridgehead International Limited, June, p. 4. Available at http://www.the-infoshop.com/study/bdg21413_biogeneric.html.