Biosimilars Approvals in the US: The Path Forward - An in-depth analysis of the patent provisions of the new legislation. - BioPharm International

ADVERTISEMENT

Biosimilars Approvals in the US: The Path Forward
An in-depth analysis of the patent provisions of the new legislation.


BioPharm International
Volume 23, Issue 9

REFERENCES

1. International Conference on Harmonization. ICH harmonized tripartite guideline: Q5E comparability of biotechnological/biological products subject to shanges in their manufacturing process. 70 Fed. Reg. 37861–62. 2005 Jun 30. See also FDA Guidance concerning demonstration of comparability of human biological products, including therapeutic biotechnology-derived products. 61 Fed. Reg. 18612–13. 1996 Apr 26.

2. Berlex Laborat ories, Inc. v. FDA, 942 F. Supp. 19, 25 (D.D.C. 1996).

3. US Food and Drug Administration. Dockets. Available from: http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4389s1-01-FDA.pdf; http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4389b1-04-Genzyme.pdf. See also http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125291s000TOC.cfm.

4. Federal Trade Commission Report. Emerging Health Care Issues: Follow-on biologic drug competition 2009. Jun; 52–63. Available from: http://www.ftc.gov/os/2009/06/P083901biologicsreport.pdf (PDF pages 68-79). See also http://www.ftc.gov/os/comments/healthcarecompissues/537778-00009.pdf and http://www.ftc.gov/os/comments/healthcarecompissues/537778-00032.pdf.

5. Biogen, Inc. v. Schering AG, 954 F. Supp. 391 (D. Mass. 1996). See also Biogen, Inc. v. Berlex Laboratories, Inc., 318 F.3d 1132 (Fed. Cir. 2003).

6. Schering Corp. & Biogen, Inc. v. Amgen Inc., 969 F. Supp. 258 (D. Del. 1997). See also Schering Corp. & Biogen, Inc. v. Amgen Inc., 222 F.3d 1347 (Fed. Cir. 2000).

7. Genentech, Inc. v. Boehringer Mannheim, 47 F. Supp. 2d 91 (D. Mass. 1999).

8. Kleid DG. Patent Litigations. In: Scientist and patent agent at Genentech: An oral history conducted in 2001 and 2002 by Sally Smith Hughes for the Regional Oral History Office. The Bancroft Library. University of California, Berkeley; 2002. Available from: http://content.cdlib.org/view?docId=hb1t1n98fg;NAAN=13030&doc.view=frames&chunk.id=div00167&toc.depth=1&toc.id=div00047&brand=calisphere.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

American CryoStem and Rutgers University File Joint Patent on Stem Cell Platform
April 11, 2014
PhRMA Report Reveals Growth Trajectories and Policy Factors Affecting Biopharmaceutical Growth
April 11, 2014
Center for Biologics Evaluation and Research Relocates
April 11, 2014
FDA Develops Alternative Assay to Increase Availability of Influenza Vaccines
April 10, 2014
Merck Announes Management Changes
April 7, 2014
Author Guidelines
Source: BioPharm International,
Click here