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BRICS countries will create a barrier-free regulatory
regime for biosimilars
(MOSCOW) - The HSE University BRICS Competition Law and Policy
Centre
has summarized the first
results of its annual
analytical study on bringing
biotechnological drugs to
the BRICS market. One of the
conclusions of the report
was the need to conduct a
large-scale sectoral study
on the removal of barriers
in the pharmaceutical
industry in the BRICS
region. As a first step, it
is proposed to focus on a
relatively narrow but very
promising topic - the
development of biologics
markets and accelerating the
entry of biosimilars into
the BRICS markets.
Biological drugs are
synthesized from living
cells (plasma, blood, etc.)
using the most advanced
biotechnology available
today. They are capable of
curing the most serious and
rare diseases. However,
since colossal resources are
spent on research and
development of such drugs,
their prices are the highest
in the world. The cost of a
single dose can exceed $3
million, the study says.
This, according to the
researchers, creates
barriers for developing
countries. Generics of
biological drugs are 70-90%
cheaper than original drugs
and no less effective.
Experts estimate the
potential of the biosimilars
market at least $100 billion
by the end of this decade.
That is why experts of the
BRICS Working Group on
Competition in
Pharmaceutical Markets call
for the removal of barriers
to the regulation of the
turnover of biological drugs
and biosimilars in the
BRICS+ countries. The
biologics market reflects
many of the problems and
contradictions of the BRICS
pharmaceutical markets.
Firstly, because this is a
cutting-edge area not only
for BRICS countries, but
also for the whole world,
and secondly, it touches
upon the acute problems of
innovative development,
intellectual property,
availability of drugs, and
external and internal
competition.
‘At this
stage, we do not aim to
create a single market, our
goal is healthy competition
within BRICS through the
removal of barriers,
primarily barriers to entry
into the pharmaceutical
markets of the BRICS member
countries. BRICS-wide
projects can be developed
through bilateral and
multilateral formats of
cooperation. Naturally,
there are legal and
regulatory peculiarities and
different requirements to
standards, but these
requirements should not
become an insurmountable
obstacle and should not be
used by countries for
protectionist purposes only.
Within BRICS, such
unreasonable barriers that
are not dictated by the
logic of security or
efficiency should be
removed,’ explains Alexey
Ivanov, Director of the
BRICS Competition Law and
Policy Centre.
It is
important to realize that
competition authorities can
have a significant impact on
pharmaceutical market
reformulation and
development, not just
competition protection. The
BRICS countries do not have
a common legal regime and
experts note that there is a
lot of work to be done. By
the next meeting of the
Working Group on
Pharmaceutical Markets, to
be held in Kazan in March
2025, the Working Group
members plan to present the
concept, structure,
composition and timing of a
sectoral study that will
help lay the groundwork for
launching a pilot project to
remove regulatory barriers
in this area. India could be
one of the first countries
to implement the pilot
project.
‘The global
biosimilars market will
exceed a turnover of $60
billion by 2030 and India
has every chance to take a
share of at least 10% in it.
At the moment, the direction
of biosimilar drugs is
actively developing, 90
products have already been
registered in India, while
only 45 have been registered
in the US - this is a very
significant number. It is
important that India is not
alone in this, we see great
potential for cooperation in
the niche of biosimilars in
the BRICS space. In many
areas, such co-operation can
reduce the cost of
production of
pharmaceuticals by more than
90%, such as, for example,
filgrastim, teriparatide,
etc.,’ emphasized Samir
Kulkarni, Professor at the
Institute of Chemical
Technology, Mumbai, member
of the Centre’s research
team.
Members of
BRICS+ include Brazil, China,
Egypt, Ethiopia, India,
Iran, the Russian
Federation, South Africa,
and the United Arab
Emirates.
SOURCE
BRICS Competition Law and Policy
Centre
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