Biobetters and the Future Biologics Market - Despite their difficult approval pathway, biobetters offer the potential for innovation and decreased healthcare costs. - BioPharm International

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Biobetters and the Future Biologics Market
Despite their difficult approval pathway, biobetters offer the potential for innovation and decreased healthcare costs.


BioPharm International
Volume 24, Issue 11, pp. 31-35

REFERENCES

1. EC Directive 2004/27/EC, amending Directive 2001/83/EC The Community Code Relating to Medicinal Products for Human Use (Brussels, March 2004).

2. TGA News, 57, November 2009.

3. Health Canada, Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (Ottowa, March 2010).

4. MHLW, Guideline for the Quality, Safety and Effectiveness of Biosimilar Products (in Japanese) http://wwwhourei.mhlw.go.jp/hourei/doc/tsuchi/2005I210304007.pdf.

5. H. Schelleckens, Eur. J. Hosp. Pharm. 10, 243–247 (2004).

6. EMA, "Questions and Answers on the Withdrawl of the Marketing Authorization for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel" (London, 2008).

7. M. McCamish and G. Woollett, mAbs 3 (2), 212–220 (2011).

8. Federal Trade Commission, "Emerging Health Care Issues: Follow-on Biologic Drug Competition" (Washington, DC, June 2009).

9. J. Woodcock et al., Nat. Rev. Drug Disc. 6, 437–442 (2007).

10. A. Sheppard, Pharm. Tech. 22 (9), 72–74 (2010).

11. H Teissel, presentation at Sandoz Day Investors Event (September, 2008).

12. Novartis Q4/full year 2010 results, January 2011.

13. H. Grabowski, Nat. Rev. Drug Disc. 7, 479 (2008).

14. M.D. Green et al., Ann. Oncol. 14, 29–35 (2003).


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