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

ADVERTISEMENT

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).


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Suppliers Seek to Boost Single-Use Technology
August 21, 2014
Bristol-Myers Squibb and Celgene Collaborate on Immunotherapy and Chemotherapy Combination Regimen
August 20, 2014
USP Center in Ghana Receives International Lab Accreditation
August 15, 2014
USP Awards Analytical Research
August 15, 2014
FDA Warns about Fraudulent Ebola Treatments
August 15, 2014
Author Guidelines
Source: BioPharm International,
Click here