Reactions to the bills
The Waxman bill enjoys the support of the Generic Pharmaceutical Association. It would enable FDA to take a case-by-case approach
to approving these therapies. "We're interested in flexibility for good science rather than in a rigid, predetermined structure,"
says Marc Goshko, executive director of legal affairs at Teva Pharmaceuticals (North Wales, PA).
BIO supports the Eshoo bill. Merck recognizes the need for an abbreviated approval pathway for follow-on biologics. "There
still remains a need for clinical studies to demonstrate safety, efficacy, and lack of deleterious immunogenicity for bio-similar
products," says Cannon.
As science and manufacturing technologies improve, biopharmaceuticals will become easier to produce. An approval process for
follow-on biologics in the US would help improve patients' health and make needed medicines more affordable. In the absence
of international standards for follow-on biologics approval, Congress must create a regulatory pathway through legislation.
At a minimum, an approval mechanism must ensure that follow-on products react in the human body the same way as their respective
reference products, says Bill Haddad, CEO of Biogenerics (Brewster, NY). A pathway should also provide patent protection for
innovators' products and allow patents to be challenged.
Despite ongoing debate, some believe that an approval pathway could be established soon. "It took us 35 years to reach Hatch–Waxman
from the early efforts of Senator Estes Kefauver," says Haddad. "It won't take us that long to get a fair and equitable biotech
law. When the dust settles, as it did following Hatch–Waxman, we will look back and wonder, 'What in the hell was all the
1. FDA, "Generic Drugs: Questions and Answers,"
http://www.fda.gov/cder/consumerinfo/generics_q&a.htm, accessed Apr. 27, 2009.
2. World Health Organization, "WHO Informal Consultation on International Nonproprietary Names (INN): Policy for Biosimilar
http://www.who.int/entity/medicines/services/inn/BiosimilarsINN_Report.pdf, accessed Apr. 27, 2009
3. FDA, Guidance for Industry: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing
Process (Rockville, MD, June 2005)
http://www.fda.gov/CbER/gdlns/ichcompbio.htm, accessed Apr. 30, 2009
4. D. McCormick, "Small Changes, Big Effects in Biological Manufacturing," Pharm. Technol.
28 (11), 16 (2004).
5. Biotechnology Industry Organization, "Why is Patient Safety a Concern in the Biosimilars Debate?"
http://www.bio.org/healthcare/followonbkg/PatientSafety.asp/, accessed May 4, 2009
6. Code of Federal Regulations, Title 42, The Public Health and Welfare (General Services Administration, Washington, DC, 2003), sec. 262,
http://www.fda.gov/opacom/laws/phsvcact/sec262.htm, accessed May 4, 2009.
7. Berlex v. FDA et al., US District Court for the District of Columbia, Oct. 7, 1996,
http://www.fda.gov/ohrms/dockets/dailys/04/mar04/031904/80n-0208-ref0001-19-Tab-11-vol126.pdf, accessed May 15, 2009.
8. C. Webster et al., "Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?" Biopharm. Int.
16 (7), 28–37 (2003).
9. G. Perry, "Biosimilar Medicines: Towards Global Development and Monoclonal Antibodies," presented at the 7th EGA Annual
Symposium on Biosimilar Medicines, London, Apr. 2009.
10. H.R.1427, "Promoting Innovation and Access to Life-Saving Medicine Act," US House, 111th Congress, 1st Session (Washington,
DC), Mar. 11, 2009, http://thomas.loc.gov/cgi-bin/query/F?c111:1:./temp/~c111RCfWrl:e0:/, accessed May 5, 2009.
11. H.R.1548, "Pathway for Biosimilars Act," US House, 111th Congress, 1st Session (Washington, DC), Mar. 17, 2009, http://thomas.loc.gov/cgi-bin/query/F?c111:1:./temp/~c111S3Mkrr:e0:/, accessed May 5, 2009.