Assessing Development Needs for Biobetters and Biosimilars - Development requirements and regulatory guidance for biosimilars and biobetters. - BioPharm International

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Assessing Development Needs for Biobetters and Biosimilars
Development requirements and regulatory guidance for biosimilars and biobetters.


BioPharm International
Volume 26, Issue 2, pp. 28-32

REFERENCES

1. Pharmaceutical Research and Manufacturers of America, PhRMA Pharmaceutical Industry Profile (2011).

2. W. Armstrong, "MedImmune Bets Its Fate on 'Biobetters,'" Sept. 9, 2010, http://www.blog.PharmExec.com/, accessed Sept. 14, 2010.

3. Roche, Pegasys label, 1–15 (Oct. 2012).

4. Genentech, a member of the Roche group, "Genentech's Targeted Investigational Breast Cancer Medicine, Trastuzumab Emtansine (T-DM1), Reduced the Risk of Cancer Worsening or Death by 35 Percent in Pivotal Phase III Trial" (San Francisco, CA, June 2, 2012).

5. Generics and Biosimilars Initiative, "US$67 Billion Worth of Biosimilar Patents Expiring Before 2020," Jun. 29, 2012, http://www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020/, accessed Sept. 14, 2010.

6. EC Directive 2004/27/EC, Amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Brussels, March 2004).

7. EC Directive 2003/63/EC, Amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Brussels, June 2003).

8. EMA, Guideline on similar biological medicinal products (London, October2005).

9. EMA, Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues (London, Feb. 2006).

10. EMA, Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Nonclinical and Clinical Issues (London, Feb. 2006).

11. EMA, Draft Guideline: Similar Biological Medicinal Products Containing Recombinant Follicle Stimulating Hormone (London, Nov. 2011).

12. EMA, Draft Guideline: Similar Biological Medicinal Products Containing Recombinant Interferon Beta (London, Dec. 2011).

13. EMA, Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies: Nonclinical and Clinical Issues (London, Jun. 2012).

14. EMA, Guideline on Similar Biological Medicinal Products Containing Recombinant Erythropoietens (London, Apr. 2010).

15. EMA, Guideline on Similar Biological Medicinal Products Containing Low Molecular-Weight Heparins (London, Apr. 2009).

16. EMA, Guideline on Non-Clinical and Clinical Development of Similar Biological Medicinal Products Containing Recombinant Interferon Alpha (London, Jun. 2009).

17. K. Srinivas Sashidhar, "Biobetters – Advent of a New Concept," Nov 28, 2011, http://www.frost.com/prod/servlet/market-insight-top.pag?docid=247671489/, accessed Sept. 14, 2010.

18. EMA, Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins (London, Jan. 2007).

19. FDA, Guidance for Industry, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf (09 Feb 2012)

20. Public Law 111–148, US Senate, 111th Congress, Sections 7001–7003 "Biologics Price Competition and Innovation Act of 2009," Mar. 23, 2010 (Washington, DC).

21. FDA, "FDA Approves New Treatment for Severe Neutropenia in Certain Cancer Patients," Aug. 29, 2012, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317392.htm, accessed Sept. 14, 2010.

22. Reuters, "FDA Approves Teva version of Amgen's Neupogen," Aug. 29, 2012, http://www.reuters.com/article/2012/08/29/us-teva-idUSBRE/ 8751CV20120829, accessed Sept. 14, 2010.

23. EMA, Assessment Report for Tevagrastim, international proprietary name filgrastim, Procedure Number EMEA/H/C/827 (London, 2008).

24. EMA, European Public Assessment Form (EPAR) Tevagrastim (London, Sept. 2008).


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