Various legislative bills would allow greater use of generic drugs.
A new legislative bill — H.R. 1548 — or the “Pathway for Biosimilars Act” was intended to provide an abbreviated process for the Food and Drug Administration (FDA) to approve generic biological products, also referred to as biosimilars or follow-on biologics.
This new biosimilars bill is biotech’s version of the Hatch-Waxman Act of 1984 which allowed for the approval of generic versions of chemically-synthesized pharmaceutical drugs. Democratic Representative Henry Waxman, who sponsored the original legislation creating generic small molecule drugs, is currently sponsoring a bill that would allow five years of exclusivity for original biotech products (biologics).
Last month, supporters of the Pathway for Biosimilars Act, an alternative to the Waxman bill that would allow the Food and Drug Administration (FDA) to approve generic versions of complex biotech drugs, is putting increasing pressure Waxman. Biologics or biological drugs are thought of as more complex, larger molecules than traditional chemical drugs and they are made from recombinant DNA processes in living host cells in cell culture.
“The drug industry has been engaged in a massive and expensive lobbying campaign to convince the members of this committee that the supply of life-saving drugs will dry up if they don’t get triple the monopoly protection available to all other drugs,” said Waxman, chairman of the Committee on Energy and Commerce.
In particular, Waxman is concerned with the drug industries’ arguments for longer periods of exclusivity without competition. Waxman’s position has been that he had seen “little or no persuasive evidence” to support industry claims that biotech companies need 12 to 14 years of exclusivity in order to at least earn back the money put into development of the biotech drugs. The longer exclusivity period is one of the key differences in the alternative bill.
The key supporter of the alternative to Waxman’s bill is Representative Anna Eshoo, a Democrat from California. Eshoo noted that if her supporters and Waxman are unable to reach an agreement, on exclusivity and other issues, including the need for additional clinical trials for immunogenicity testing, they will pursue an amendment to incorporate the alternative bill measures into the committee draft. Currently, the FDA does not have an approval pathway for biosimilars. In contrast, in Europe, the European Medicines Agency (EMEA) has approved at least six biosimilars, including insulin and human growth hormone.
Lisa Haile is an attorney specializing in life sciences.
Clearly, the generic drug industry would like to begin producing the cheaper versions of the biologics sooner than the brand name companies would like. There are many differences between the Waxman bill and Eshoo’s bill, but a key one is the length of time that biotech drugmakers would have exclusivity. The discussions on a regulatory pathway for biosimilars are at least 10 years old at this point — hopefully we will see resolution in the near future on this issue.
Dr. Lisa A. Haile is a partner at DLA Piper LLP US and co-chair of the firm’s Global Life Sciences Sector Group. Her practice focuses on strategic counseling relating to all areas of biotechnology and life sciences intellectual property law. Web: www.dlapiper.com/lisa_haile Twitter: @dnajd Email: lisa.haile@dlapiper.com
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