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Another central issue in the debate is the extent to which exclusivity
is necessary as an incentive for innovators to continue to improve
their already-approved drugs, and how that exclusivity should
be framed. The single six-month extension for improvements in
the Waxman bill, as well as the requirement that a supplement
containing the improvement be approved before the ﬁ nal year
of exclusivity, appear to be designed to address claims that the
current system encourages innovators to wait until the end of
their exclusivity to seek approval for product improvements, and to
employ product improvements in a manner that unfairly extends
their market protection.
A third signiﬁ cant issue is whether Congress should impose
minimum requirements or prescribe minimum standards for the
amount of clinical data that a follow-on sponsor must submit to
been approved in any previous BLA or that is highly similar to a
obtain approval.
major substance approved in a previous BLA. The circumstances Nevertheless, despite the signiﬁ cant issues that still remain
under which ﬁ ve-year exclusivity would be awarded are not clear,
unsettled, most FDA-watchers agree that Congress is likely to pass a
given that “major substance” is not deﬁ ned in the Waxman bill.
follow-on biologics bill either this year or next.
Also, because the exclusivity would bar approval of an Abbreviated
Biologics License Application (ABLA), but not its submission or its Conclusion
review by the FDA, the beneﬁ t to the innovator would be less than
Some aspects of the obligations to be fulﬁ lled in an application for
what is available under the Waxman-Hatch NCE exclusivity.
authorisation of a biosimilar in the EU are reﬂ ected in the proposed
Three-year exclusivity would be available for a biologic that contains
Waxman bill. Biosimilarity between the two products would be
a major substance that was in a biologic previously-approved via
demonstrated in accordance with requirements similar to those laid
a BLA, if new clinical investigations are required. However, the
down in EU law. Moreover, the biosimilar may, as in the EU, have
exclusivity would be rewarded only if the product represents a
the same INN as its reference biologic.
“signiﬁ cant therapeutic advance,” such as a “signiﬁ cant” new
32 However, giving biosimilar applicants a regulatory pathway to
indication or subpopulation, other than a paediatric indication.
demonstrate interchangability would reﬂ ect both a fundamental
An applicant could not receive three-year exclusivity for such
difference between EU and US laws concerning authorisation of
innovations to its own product, unless they resulted in a product
biosimilars and a fundamental difference between the roles of
requiring submission of a new BLA (as opposed to a BLA
the European Commission and the FDA in the authorisation of
supplement). Thus, the issue of whether a new BLA is required or
medicinal products.
permitted for a given change or improvement may take on even
greater signiﬁ cance.
The difference between the EU and US approaches to the issue of
market exclusivity that is found in existing legislation governing
An applicant would be able to extend its three- or ﬁ ve-year
the marketing of medicinal products (small-molecule drugs in the
exclusivity by six months by obtaining approval of a BLA supplement
US) is also reﬂ ected in the proposed US legislation on biosimilars.
that requires new clinical investigations and that incorporates a
Currently, while an innovative product placed on the market in
signiﬁ cant therapeutic advance. Only one six-month extension would
the EU, whether it is a chemical product or a biologic, is entitled
be allowed for any product, and the supplement would have to be
to market exclusivity of 10 years, the equivalent non-biologic drug
approved before the ﬁ nal year of the exclusivity period. Additionally,
product would be entitled to only ﬁ ve years’ market exclusivity in
if the product has annual US sales greater than w$1 billion, the
the US (recognising that the US exclusivity period may be extended
extension would be reduced to three months. Taken together, these
in the event that the innovator’s patents are litigated). If the
provisions indicate that it will be difﬁ cult for an applicant to obtain
Waxman bill is adopted in its present form, it would adopt a similar
signiﬁ cant beneﬁ ts from many product innovations.
ﬁ ve-year marketing exclusivity period for biosimilars.
Despite the fact that there appears to be general support in
At present, it seems likely that biosimilars will become the subject
Congress for biosimilar legislation, there is still considerable
of speciﬁ c legislation in the US. Whether this will lead to any type
uncertainty and disagreement regarding a number of key issues.
of a harmonisation of approach between the US and the EU will,
Chief among these is the number of years of “new major
however, remain to be seen.
substance” market exclusivity that would be available to innovative
biologics. While the Waxman bill proposed ﬁ ve years of exclusivity, The authors are partners at the law fi rm Hogan & Hartson.
others in Congress have proposed that the exclusivity period should Robert F Church is based in Los Angeles, Michael N Druckman
be as long as 12 years. in Washington, DC, and Elisabethann Wright in Brussels.
Scrip World Pharmaceutical News Supplement August 2009
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