infringement litigation ends with a determination that the patent is Act”. Mr Waxman’s bill is not the only piece of draft legislation that
invalid or not infringed. merits attention, but given his keen interest in the subject and his
position as chair of the Energy & Commerce Committee, it will be
In addition to fi ve-year NCE exclusivity, Waxman-Hatch also created
three-year new use exclusivity. Among other things, this provision
an important reference point for all future discussions on biosimilars.
of the FDCA comes into play when a sponsor submits a supplement Mr Waxman’s bill is complex and a full assessment of it is beyond
to an approved NDA proposing a change in the conditions of use of the scope of this article. However, the following discusses specifi c
an approved drug. In these cases, when certain statutory criteria are noteworthy aspects of the legislation.
met, the product may receive three years of marketing exclusivity if
the application contains data from one or more studies that the FDA
Approval of biosimilars
considers essential to approval.
Biosimilarity or interchangeability would be demonstrated by (1)
chemical, physical and biological assays and other non-clinical
Like other drug approval provisions in the FDCA, Waxman-Hatch
laboratory studies, and (2) “necessary” clinical studies suffi cient
is not applicable to the licensing process for biological products
to confi rm safety, purity and potency. The FDA would determine
under the Public Health Service Act. Nevertheless, precedent
what clinical studies, if any, are necessary, and the bill warns that
and experience under Waxman-Hatch undoubtedly will inform
any studies must be designed to avoid duplicative and unethical
the legislative debate over an abbreviated approval pathway for
clinical testing. These provisions suggest that product- or process-
biologics, as well as the manner in which the FDA and the courts
specifi c assays may assume a greater role in an abbreviated approval
will interpret the language in any legislation that Congress enacts.
pathway for biologics.
Recent efforts to create an abbreviated approval pathway for
The FDA may give a biosimilar the same offi cial or non-proprietary
follow-on biologics
name as the reference product, even if the two products are not
With its continued focus on the cost of healthcare, the US Congress
found to be interchangeable. This may raise substitution issues
has begun working to create an abbreviated approval pathway for
under state pharmacy laws, given how prescriptions are written.
follow-on biologics. As an example, in March 2009, Representative
Henry Waxman (one of the authors of the Waxman-Hatch
Marketing exclusivities
amendments to the FDCA) introduced a bill into Congress entitled A Biologics License Application (BLA) would be given fi ve years of
the “Promoting Innovation and Access to Life-Saving Medicine exclusivity if the product contains no “major substance” that has
31
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Scrip World Pharmaceutical News Supplement August 2009
cphi.com | icsexpo.com | p-mec.com | bioph-online.com
wherepharmameets.com | scripnews.com
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