Biosimilars in the United States: A brief look at where we are and the road ahead

Biotechnology Law Report

Volumn 26, Issue 5, 2007, Pages 463-467

  Morrison, Alan J ^a  

^a Cohen Pontani Lieberman and Pavane LLP ^*

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EID: 38149051649     PISSN: 0730031X     EISSN: None     Source Type: Journal    
DOI: 10.1089/blr.2007.9914     Document Type: Article

References (57)

1. Biologies are known by various names, such as biopharmaceuticals and biologic drugs, which are used synonymously here. Likewise, biosimilars are referred to alternatively as generic biologies, follow-on biologies, and biogenetics. These terms are used synonymously here, noting that using the term "generic" in connection with biologies has, for technical reasons, been deemed by some to be inaccurate.
2. 733 F.2d 858, 221 USPQ 937 (Fed. Cir. 1984).
3. John R. Thomas, PHARMACEUTICAL PATENT LAW, Chapter 1.IV.A (BNA) (2005).
4. Roche v. Bolar, 733 F.2d at 876-877.
5. The Drug Price Competition and Patent Term Restoration Act [Public Law No. 98-417] is commonly referred to as the HatchWaxman Act or the Waxman-Hatch Act.
6. FDCA §505(j); 21 U.S.C. §355(j). See Daniel O. Beers, GENERIC AND INNOVATOR DRUGS: A GUIDE TO FDA APPROVAL REQUIREMENTS, Sixth Ed. (2004), §3.01, fn 1. In all, the Hatch-Waxman Act was codified in 15 USC §§68b-68c, 70b; 21 USC §§301, 355, 360cc; 28 USC §2201; and 35 USC §§156, 271, 282.
7. See also, Thomas, PHARMACEUTICAL PATENT LAW, Chapter 1.IV.B.
8. See, e.g., FDCA §505(j); 21 USC §355(j).
9. Frequently Asked Questions, Generic Pharmaceutical Association (available online at www.gphaonline.org/Content/NavigationMenu/AboutGenerics/FAQs/default. htm) (accessed June 21, 2007).
10. Backgrounder on Biologies, Issues and Legislation sponsored by Rep. Henry Waxman (online at www.henrywaxman.house.gov/issues/health/generic_biologics. htm) ("Backgrounder"), citing Generic Drugmakers Await End of Patents: The Generic Drug Industry Will Be Buoyed as 75 Brand-Name Prescription Drugs Lose Their Patent Protections, Knight-Ridder (May 2, 2006).
11. Industry Statistics, Generic Pharmaceutical Association, June 21, 2007 (available online at www.gphaonline.org/Content/NavigationMenu/AboutGenerics/ Statistics/default.htm) (accessed June 21, 2007) ("Industry Statistics").
12. Backgrounder, citing Generic Pharmaceutical Association, Statistics: Our Industry (available online at www.gphonline.org/Content/NavigationMenu/ AboutGenerics/Statistics/default.htm) (accessed February 13, 2007).
13. Industry Statistics.
14. Id.
15. P.H.S.A. §351(i), 42 U.S.C. §262(i).
16. Backgrounder, citing Biotechnology Industry Organization, Healthcare Overview (available online at www.bio.org/health-care) (accessed February 12, 2007).
17. Backgrounder, citing Pharmaceutical Research and Manufacturers of America (PhRMA), Biotechnology Medicines in Development, 2006 Report (online at www.phrma.org/files/Biotech%202006.pdf) (accessed February 13, 2007).
18. Backgrounder, citing Drugmakers' Battle for Medicare Market Share, CQ Weekly (October 2, 2006) (citing Centers for Medicare and Medicaid Services [CMM]).
19. Gearing up for Bio-Generics, Signals Magazine, October 5, 2006 (available online at www.signalsmag.com/signalsmag.nsf/0/ C3985651BF9C5D7E882571FE000A2575).
20. Id.
21. Id.
22. Backgrounder, citing Kuhn, Director CMM, Testimony before the House Subcommittee on Health of the Committee on Ways and Means (July 13, 2006) (available online at http://waysandmeans.house.gov/hearings.asp?formmode= view&id=5108) (accessed February 13, 2007).
23. Frequently Asked Questions about Therapeutic Biological Products, U.S. Food and Drug Administration, Center for Drug Evaluation and Research (online at www.fda.gov/cder/biologics/qa.htm).
24. Id.
25. Waxman, Schumer, and Clinton Unveil Bill to Create Clear Pathway for Generic Biologic Drugs (February 14, 2007) (online at www.henrywaxman.house. gov/pdfs/biologicspressrelease_2.14.07.pdf).
26. Terms such as "comparability," "similarity," and "interchangeability" are featured in the proposed biosimilars legislation, discussed below.
27. Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States, Statement of Janet Woodcock, M.D., Deputy Commissioner, Chief Medical Officer, Food and Drug Administration before Subcommittee on Health, Committee on Energy and Commerce, May 2, 2007. (Available online at www.fda.gov/ola/2007/policy05022007.htail) ("Woodcock").
28. H.R. 1038, introduced February 14, 2007 and sponsored by Rep. Henry Waxman (available online at http://www.henrywaxman.house.gov/issues/health/ generic_biologics.htm); S. 623, introduced February 15, 2007 and sponsored by Senators Hillary Clinton and Charles Schumer (available online at www.law.columbia.edu/null?&exclusive=filemgr.download&file_id= 12252&rtcontentdisposition=filename%3DS%20623.pdf).
29. H.R. 1038, §2(a)(4).
30. Id. at §2(a)(5).
31. See, e.g., id. at §2(a)(4)(B).
32. Id. at §3(a)(10).
33. Id. at §3(a)(17), (b)(1).
34. Id. at §3(a)(17)(B).
35. H.R. 1956, introduced April 19, 2007, and sponsored by Reps. Jay Inslee, Gene Green, and Tammy Baldwin (available online at www.house.gov/inslee/docs/ pdfs/biologics_bill_april_2007.pdf).
36. H.R. 1956, §2(a)(2), which adds §(k)(I)(A) to the PHSA.
37. Id. at §2(a)(2), which adds §(k)(3)(A)-(C) to the PHSA.
38. S. 1695, introduced June 27, 2007 and sponsored by Senators Edward Kennedy, Hillary Rodham Clinton, Michael Enzi, and Orrin Hatch (available online at http://thomass.loc.gov/cgi-bin/query/C?c110:./temp/~c110X9tE3E).
39. See, e.g., S. 1695, §2(a).
40. S. 1695, §2(b)(3)(2).
41. Id. at §2(b)(3)(3).
42. Id. at §2(a)(k)(2)(A)(i)(I)(aa)-(cc).
43. W. at §2(a)(k)(2)(A)(ii).
44. Id, at §2(a)(k)(4)(A)(i) and (ii).
45. Id. at §2(a)(k)(7)(A).
46. See, e.g., S. 1695, §2(a)(k)(6)(A)-(C), setting forth the exclusivity period granted for a first interchangeable biological product.
47. GPhA Statement on Sens. Kennedy-Enzi-Clinton-Hatch Biogenetics Legislation, Generic Pharmaceutical Association, June 27, 2007 (available online at www.gphaonline.org/AM/Template.cfm?Section=Press_Releases&TEMPLATE=/CM/ HTMLDisplay.cfm&ContentID=3560).
48. S. 1695, §2(a)(1)(2)(A).
49. Id. at §2(a)(1)(3)-(5).
50. Id. at §2(a)(1)(6)(A) and (B).
51. Id. at §2(a)(1)(8)(A).
52. Id. at §2(a)(1)(8)(B). As used in this context, a patent that is "relevant" to the biosimilar product is one that is listed pursuant to S. 1695, §2(a)(1)(3)(A) or (B).
53. See, e.g., The Future of Biologies - Examining Market Competition, Innovation and Patient Safety, Remarks by Sen. Orrin G. Hatch before the U.S. Chamber of Commerce (April 25, 2007) (available online at http://hatch.senate.gov/index.cfm?FuseAction=PressReleases.View& PressRelease_id=1796) ("Hatch").
54. See, e.g., Woodcock and Hatch.
55. Generic Biologic Drugs Unlikely to Offer Significant Savings, Medical News Today (May 6, 2007) (available online at http://www. medicalnewstoday.com/printerfriendlynews?newsid=69584) (accessed May 23, 2007).
56. Id.
57. June 5, 2007 personal communication with Congressional Staffer. See, also, Hopes for Speedy Action on Generic Biologics Bill Fade in Senate, Biologic Drug Report (April 16, 2007) (available online at http://www.bio. logicdrugreport/News/news-041.607.htm) (accessed June 8, 2007).