'Biosimilars' refer to products which are similar to a
biological product that has already been authorised for use. As the
name suggests, the complexities of manufacturing these products
means that whilst they may be closely similar to the original
"innovator" product, they are not identical.
The European Medicines Agency has only authorised a few
biosimilars since the first such authorisation in 2006, and has
been at the forefront of developing a specific procedure for the
authorisation of such products through the centralised procedure.
Despite this innovation, the use of the centralised procedure has
posed challenges, especially where the patent for the original
biosimilar compound has expired, but there is patent protection for
a second medical use of that compound. Under the centralised
procedure there is no mechanism to remove the patented indication
from the Summary of Product Characteristics (the "SmPC")
or Patient Information Leaflets ("PIL") for those
countries where that use is protected. This leaves the manufacturer
at risk of allegations of patent infringement. Therefore, where the
manufacturer of a biosimilar wishes to launch in those countries
where the second medical use is patent protected, it must submit a
duplicate application with the necessary carve out on the
Under article 82(1) of Regulation 726/2004:
"the Commission shall authorise the same applicant to
submit more than one application to the Agency for that medicinal
product when there are objective verifiable reasons relating to
public health regarding the availability of medicinal products to
health-care professionals and/or patients, or for co-marketing
A common reason to allow duplicates is where an indication in
the original application is protected by a patent in a Member
State. Although this may overcome the issue of the carve out, it in
turn creates further issues. Although it is clear that the original
application and the duplicate are the same product, under EU
regulations each application requires a separate name for the
medicinal product to be submitted. This has an impact on patient
care, for the same product will have a different name in different
countries. This may result in patients being prevented from
accessing their prescribed medicine in different countries, but it
may also create confusion for both patients and healthcare
professionals alike. Once the second use patents have expired,
doctors would need to switch the name of the prescribed medicine to
that used in the original application to ensure harmonisation.
Indeed the applicant must provide a commitment letter upon
application undertaking to ensure that once the patent expires, the
shortened label is extended to include the indication that was
patent protected. In that respect, it is essential that both labels
bear the same name. Otherwise, a company will have to re-market the
product under the new (and harmonised) name once the patent
expires, which has financial implications for manufacturers.
Overcoming these issues would require a reinterpretation of EU
regulations. Either the indications that are patent protected by
the second medical use are removed before marketing the product in
those Member States that afford that protection, or duplicates that
are solely applied for due to such patents are allowed to bear the
same name. The former approach could be justified under article 11
of Directive 2001/83, and would mean that the centralised procedure
is brought into line with the decentralised procedure. The latter
approach would require a new interpretation of article 6 of
Regulation 726/2004, which states that each application for
authorisation "shall include the use of a single name for
the medicinal product". However, as the original and
duplicate applications are for the same product, this
interpretation should not be problematic.
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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After studying bioengineering and completing a PhD in the San Francisco Bay Area and a two-year postdoctoral research fellowship in London, Mark has spent the past four years analysing global health policy.
World AIDS Day, held on the 1st December each year, provides an opportunity for people to unite in the fight against HIV and show their support for people living with, or having died as a result of, HIV.
Since the enactment of Directive 2001/83/EC ("Community Code Directive") the European Community has conducted a comprehensive review of its legislation on medicinal products. It is not only that the Community since then has adopted Directive 2004/27/EC amending the Community Code. In fact, several other acts of legislation have been issued.
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