Current regulatory and legal considerations for follow-on biologics

Clinical Pharmacology and Therapeutics

Volumn 84, Issue 5, 2008, Pages 633-635

  Kingham, R F ^a   Lietzan, E ^a  

^a Department of International Practice   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL FACTOR; GENERIC DRUG; GRANULOCYTE COLONY STIMULATING FACTOR;

BIOEQUIVALENCE; BIOTECHNOLOGY; COST CONTROL; DRUG APPROVAL; DRUG LEGISLATION; DRUG RESEARCH; DRUG SURVEILLANCE PROGRAM; ECONOMIC ASPECT; FOOD AND DRUG ADMINISTRATION; IMMUNOGENICITY; PRIORITY JOURNAL; SHORT SURVEY;

BIOLOGICAL PRODUCTS; BIOTECHNOLOGY; DRUG APPROVAL; DRUGS, GENERIC; EUROPEAN UNION; HUMANS; PUBLIC POLICY; TECHNOLOGY, PHARMACEUTICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 54249161815     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2008.159     Document Type: Short Survey

References (14)

1. Hutt, P.B, Merrill, R.A. & Grossman, L.A. Food and Drug Law: Cases and Materials 3rd edn. (Foundation Press, New York, 2007).
2. Kingham, R.F. & Castle, G.H. Data and marketing exclusivity for pharmaceuticals in the European Community. Food Drug Law J. 55, 209-223 (2000).
3. Woodcock, J. et al. The FDA's assessment of follow-on protein products: a historical perspective. Nat. Rev. Drug Discov. 5, 437-442 (2007).
4. Committee for Proprietary Medicinal Products. Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMEA/CPMP/3097/02/Final 〈http://www.emea.europa.eu/pdfs/human/ewp/309702en.pdf〉 (2003).
5. Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Official Journal of the European Union L 159/46 〈http://ec.europa.eu/enterprise/ pharmaceuticals/eudralex/vol-1/dir_2003_63/dir_2003_63_en.pdf〉 (2003).
6. Directive 2004/24/EC of the European Parliament and the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Union L 136 〈http://ec.europa.eu/ enterprise/pharmaceuticals/review/doc/final_publ/dir_2004_24_20040430_en. pdf〉 (2004).
7. Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products. 〈http://www.emea.europa.eu/pdfs/human/ biosimilar/043704en.pdf〉 (2005).
8. Section 351 of the Public Health Service Act, 42 U.S.C. §262.
9. Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §355(b)(2).
10. S. 1695, 110th Congress, 1st Session.
11. Casadevall, N. et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N. Engl. J. Med. 346, 469-475 (2002).
12. Food and Drug Administration. Approved Drug Products With Therapeutic Equivalence Evaluations 28th edn. 〈http://www.fda.gov/cder/orange/ obannual.pdf〉 (2008).
13. Food and Drug Administration. U.S. FDA considerations: Discussion by National Regulatory Authorities With World Health Organization (WHO) on possible International Non-proprietary Name (INN) Policies for Biosimilars. 〈http://www.fda.gov/cder/news/biosimilars.htm〉 (2006).
14. Manheim, B.S., Granahan, P. & Dow, K.J. 'Follow-on biologics': Ensuring continued innovation in the biotechnology industry. Health Aff. (Millwood) 25, 394-404 (2006).