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

Compounding Pharmacy Issues Recall, But Challenges FDA Decision
July 22, 2014
AbbVie's Acquisition of Shire Could Save $8 Billion in Taxes
July 21, 2014
AstraZeneca Reveals Design for New Global R&D Center and Corporate Headquarters
July 18, 2014
AbbVie to Acquire Shire for $54.7 Billion
July 18, 2014
Particulate Matter Prompts Baxter's Recall of IV Solutions
July 17, 2014
Author Guidelines
Source: BioPharm International,
Click here