Is Europe ahead of the USA in biosimilars?

Journal of Generic Medicines

Volumn 3, Issue 3, 2006, Pages 201-208

  DiCicco, Richard L ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

BETA1A INTERFERON; EPOETAL; FOLLITROPIN; FORTICAL; GENERIC DRUG; GLATIRAMER; GRANULOCYTE COLONY STIMULATING FACTOR; HUMAN GROWTH HORMONE; HUMAN MENOPAUSAL GONADOTROPIN; INSULIN; INTERFERON BETA SERINE; PANCREAS ENZYME; RECOMBINANT ERYTHROPOIETIN; SALCATONIN; SOMATREM; TEV TROPIN; URIBETA;

ARTICLE; COMMERCIAL PHENOMENA; DRUG APPROVAL; DRUG COST; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; DRUG SAFETY; DRUG SUBSTITUTION; EUROPE; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; LEGAL ASPECT; LICENCE; PATIENT CARE; PHYSICIAN ATTITUDE; PRACTICE GUIDELINE; PRESCRIPTION; PROFIT; REIMBURSEMENT; SAMPLE SIZE; UNITED STATES;

EID: 33751568510     PISSN: 17411343     EISSN: 17417090     Source Type: Journal    
DOI: 10.1057/palgrave.jgm.4940120     Document Type: Article

References (27)

1. See the excellent paper by Suzette Kox which explains the list of terms for biosimilars: Kox, S. (2005) 'The saga of the legal framework for biogenerics in Europe', Journal of Generic Medicines, Vol. 2, p. 105.
2. BLAs are authorised under the Public Health Service Act (42 USC 262, et seq.; 21 CFR Part 600).
3. ANDAs are authorised under the Federal Food, Drug & Cosmetic Act (FFDCA) 21 USC 355(j); CFR 314.92.
4. See NDA 21-047.
5. Serono Labs v Shalala, 158 F.3d 1313, 1320 (DC Cir. 1998).
6. FDA/DIA jointly sponsored workshop 'Scientific Workshop on Follow-on Protein Pharmaceuticals' 14th-16th February, 2005.
7. NDA 505(b)(2)s are authorised under FFDCA 21 USC 355(b)(2); 21 CFR 314.52.
8. Dudzinski, D. M. (2005) 'Reflections on historical, scientific, and legal issues relevant to designing approval pathways for generic versions of recombinant protein-based therapeutics and monoclonal antibodies', Food and Drug Law Journal, Vol. 60, pp. 143-260.
9. Currently Director of the Office of Pharmaceutical Science at FDA's CDER.
10. 'Generic Medicines: A Global Market, A Global Industry', 19th-22nd June, 2005, Malta.
11. This comes from private communication with several companies. Once approved, the BLAs will have details on the actual number of patients used.
12. See http://www.tev-tropin.com.
13. 8th Annual IGPA Conference, 'Similar Biological Medicinal Products Regulatory Perspective' Malta, 19th-22nd June, 2005.
14. BioPartners submitted alpha interferon on 25th October, 2004 for hepatitis C and then somatropin on 30th November, 2004.
15. Survey by Technology Catalysts 2005 unpublished data.
16. See Insulin CHMP/32775/05, somatropin CHMP 94528/05, EPO CHMP 94526/05 and G-CSF CHMP/31329/05.
17. For EPO, as an example, CHMP 94526/05 states 'safety data from at least 300 patients treated with the biosimilar is sufficient.'
18. Shelton, D. M. (2005) 'Whither biogenerics: An update', at: 3rd Annual Generic Pharmaceuticals Global Summit, 2nd August, 2005.
19. NDA number 21-406.
20. Citizen's Petition 2004p-0015.
21. 10th Annual EGA Conference, Amsterdam, November 8th-9th, 2004: The Generic Medicines Industry Meeting the Challenge of European Healthcare, 'Presentation of EGA's Internal Review of National Measures Affecting the Marketing of Generic Medicines'.
22. Kox, S. (2005) 'Other regulatory developments in the European Union related to "biosimilars"', 3rd EGA Annual Symposium on 'Biogenerics': Moving Forward with Biosimilar Products in Europe, 27th May, 2005, London, UK.
23. Author's personal communication with Dr Raffaella G. Balocco Mattavelli, Responsible Officer, INN Programme, Quality Assurance and Safety: Medicines, Dept. of Essential Drugs and Medicines Policy, World Health Organization, 26th July, 2005.
24. http://www.egagenerics.com: Facts & Figures: Pricing and Reimbursement Systems.
25. Mike Brownlee, Head of Medicines Pricing & Supply Branch, Dept. of Health, UK.
26. Mehta, N. M. (2004) 'Oral delivery and recombinant production of peptide hormones, Part II: Recombinant production of therapeutic peptides', BioPharm International, July 2004.
27. Investor's Conference Call, 15th August 2005. http://www.unigene.com.