Biosimilars: what differences
between the EU and the US?
Generic versions of off-patent biological products are set to become more prominent fi xtures
of the pharmaceutical landscape. Robert F Church, Michael N Druckman and Elisabethann
Wright provide contrasting perspectives on the regulatory systems governing biosimilar
products in two of the world’s major pharmaceutical markets
The distinction between generic medicinal products and “similar the biosimilar and its reference product may impact the safety and
biological medicinal products”, commonly referred to in the EU as effi cacy of the biosimilar. It has been concluded that these issues
“biosimilars”, was directly acknowledged in EU legislation by the should be addressed case by case and based on specifi c scientifi c
2004 modifi cation of the Community Code on Medicinal Products.
guidelines that are developed in refl ection of the nature of the
In the US, while there is existing legislation governing the approval
biosimilar product.
of generic drugs in place, this does not currently extend to
Legal framework
biosimilars. In this market, these products are often called “follow-
A biological medicinal product can be authorised as a biosimilar
on biologics”. US law differs from the EU regulatory system in that
in accordance with the provisions of the Community Code if it
it does not provide an abbreviated approval pathway for biosimilars.
meets the requirements set down in the Community Code and
However, in the US, the issue of biosimilars is both a matter of some
debate and the subject of a number of proposals for legislation.
the guidelines that have been prepared by the EMEA. These are
essentially that:
Below we examine aspects of the current EU biologics market
following the introduction of EU legislation governing the
• the reference product on which the authorisation of the biosimilar
authorisation of biosimilars. We also consider aspects of the
relies must have been authorised within the EU (although there is
28
proposed US legislation on biosimilars.
no requirement that the reference product must continue to be
authorised when a request for biosimilar approval is submitted);
EU aspects of biosimilars
• the eight-year data exclusivity period to which the reference
The concept of biosimilars was not part of the original Community
product is entitled under the provisions of the Community Code
Code on Medicinal Products adopted in 2001. It was introduced
must have expired; and
in its initial form by the European Commission’s 2003 revision to
• the similarity between the safety and effi cacy profi les of
the Community Code. A subsequent revision of the Community
the biosimilar and the reference product must have been
Code in 2004 introduced a specifi c reference to similar biological
demonstrated.
medicinal products, distinguishing these from generic products and
providing framework guidance on the process for their marketing It is this last requirement that essentially establishes the difference
authorisation in the EU. between an application for a marketing authorisation of a
“generic” medicinal product and that for a biosimilar product.
Basic assumptions
According to the Community Code, biosimilars fail to meet the
The rules applying to biosimilar products in the EU are based on a
criteria for “generics” due to differences relating to raw materials
number of overarching principles and assumptions. The fi rst is that
or differences in the manufacturing process. As a consequence, the
biologics are not chemical products. Biological molecules produced
results of appropriate preclinical and clinical trials relating to those
in living organisms are more complex than chemical products and
conditions must be provided.
are highly infl uenced by changes in their manufacturing process.
Consequently, it is virtually impossible to produce an identical copy
EU practice and experience
of a biologic product. Unlike chemical products it is not, therefore,
Biosimilars are authorised exclusively by the European Commission
possible to create a generic form of a biologic product.
and in accordance with the centralised authorisation procedure.
It is important to underline, as the Community Code itself
The Commission makes its decision on an authorisation application
acknowledges, that biosimilars are not “biogenerics”. They are
after receiving a scientifi c opinion from the CHMP, the EMEA’s
similar to, but not identical to, the reference product on which expert scientifi c committee. This opinion is not binding on the
their manufacturers seek to rely for their marketing authorisation Commission. However, should the Commission choose not to
in the EU. As a result, there are concerns that differences between follow it, a justifi cation must be provided for this decision.
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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