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International Clinical Trials
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The most significant reason for the rise in demand for biosimilar drugs
is the cost benefit offered by them. These products are priced around
20-30% lower than the parent/ branded product (1) – resulting in cost
savings for patients, with increased access to expensive biologic
treatments at lower prices. For instance, Remicade – used for treating
rheumatic diseases – costs $987.56 per 100mg; compare this with
Inflectra, which is priced at $650 per 100mg. Similarly, Neupogen
(biologic filgrastim) – used for treating cancer with neutropenia –
costs $174 per day, whereas the use of its biosimilar version costs $129
per day. This leads to a saving of $44 per day, and more than $600 for a
14-day course.
According to a study conducted by the
German-based Institute for Healthcare and Social Research in October
2012 (1), the use of biosimilars is expected to save $15-45 billion
across eight EU countries from 2007 to 2020. Their costeffectiveness
will also aid in meeting the need for curtailing the rising healthcare
expenditure. Thus, the decreasing cost-to-benefit ratio offered by
biosimilar drugs will, in turn, increase their demand.
Development
of a biosimilar requires significant investment, technical capability
and clinical trial expertise. The average cost for developing a
biosimilar ranges between $100-250 million, which is higher than
developing a generic version of a small molecule/pharmaceutical product.
Apart from this, biosimilar approval needs strong Phase 3 clinical
comparability trials with reference to the product.
Country-Specific
Europe
was the first region to launch biosimilar drugs into the market and now
holds a maximum share. The US, on the other hand, lags behind Europe
and Asia-Pacific due to a lack of government support and its stringent
regulatory environment. The biosimilars market in North America, in
particular, suffers from the presence of strict regulatory guidelines:
currently, only one biosimilar is approved in the US market. In addition
to this, other factors restraining the market in North America include
the costly manufacturing and purification process of biosimilars, as
well as the arrival of biobetters. Asia-Pacific, Latin America and the
Middle East offer ample opportunities to manufacturers due to the
presence of less stringent regulatory guidelines. Emerging markets such
as Argentina, Brazil, China, India, Mexico and Saudi Arabia offer
significant growth possibilities in the industry; however, the markets
in Africa, Mexico and Saudi Arabia are still in their early stages.
China
and India are considered to be attractive destinations for R&D
outsourcing for foreign biosimilar manufacturing companies that are
looking to reduce their R&D costs and, simultaneously, increase the
number of drug applications and approvals. North America and Europe –
traditional sites for clinical trials – face challenges in terms of
trial costs and patient pool. Recent health reforms in the US, patent
expiry of blockbuster drugs and the global economic meltdown have
restricted the R&D budgets of pharma companies. This is fuelling
them to look for opportunities in emerging countries that offer
advantages such as reduced costs, rapidly growing economies, rise in
technological innovation and easy access to a large pool of
heterogeneous patient population.
Fast-Growing Regions
Businesses
are focusing on Asia as a key centre of clinical trials, as the studies
conducted in these countries are nearly 50% less expensive when
compared to developed ones. Furthermore, the existence of various
diseases in emerging regions makes it easier to carry out different
types of trials. Patient enrolment is accelerated through a large
population base; what is more, the retention of participants is
unusually high, thereby facilitating trial conduct on a timely basis.
This reduces the overall time consumed in clinical studies and this, in
turn, minimises the overall cost and consequently aids product launches
in the market and post-regulatory clearance.
China’s 12th
five-year plan – from 2011 to 2015, focusing on developing generic
versions of branded biologics and expanding contract research and
manufacturing services – allotted $1.7 trillion for the development of
biopharmaceutical drugs. An additional $11.8 billion will be spent on
advancing innovations in biotechnology under the Chinese government’s
13th five-year plan. Lack of any government regulations regarding the
approval of biosimilars, and low intellectual property protection of
biologic compounds, are factors that have enabled domestic manufacturers
to market the generic versions of biologic compounds at low prices.
India
is considered an emerging market for the biosimilars industry due to
its less stringent regulatory guidelines that reduce entry barriers. In
2012, the Department of Biotechnology launched the Biotechnology
Industry Partnership Programme for Indian biosimilars companies. Under
this, the Indian government will support biotech businesses on a
cost-sharing basis to enhance existing R&D capacities for
biosimilars. The major factor attracting biopharma companies to carry
out studies in India include: easy access to patient population, as the
country has 20% of the global disease burden with a high prevalence of
chronic and lifestyle diseases; huge unmet medical needs; and cost
savings of over 60% in clinical trials compared to developed countries
across North America and Europe. The country also has well-trained
investigators and costeffective labour availability.
This
favourable clinical trial environment, with stable progressive
regulatory framework in accordance with Good Clinical Practice (GCP)
guidelines, and a large pool of GCPtrained clinical research
professionals – plus a strong IT infrastructure – make India an
attractive destination in Asia.
Australia, Brazil, Mexico and
Saudi Arabia are further prominent regions for the biosimilars market.
Factors impacting the growth in these countries are government
initiatives, less stringent regulatory guidelines, stable economic
conditions and a rise in incidences of chronic disorders.
New Opportunities
Most
of the early biologic drugs lost their patent protection in the first
half of the 20th century, while many of the current best-selling drugs
are set to lose theirs in the coming years. This creates new
opportunities for biosimilar drugs. Currently, more than 21 biologic
drugs are under the threat of losing patent protection, and these drugs
are expected to generate more than $54 billion worth of sales revenue by
2019 in the US alone. They are predominantly used for the treatment of
cancer, autoimmune disorders, diabetes and growth hormonal disorders;
the increasing incidence of these disorders is likely to increase the
demand for biosimilars as well.
Key players in the biosimilars
industry are expanding their presence in strategically important
biosimilars markets – namely China, India, Latin America, the Middle
East and South Korea – and are partnering with contract manufacturing
organisations and CROs in order to increase their production, as well as
R&D operations. Over the past two to three years, there has been a
definite surge in the number of activities related to partnerships and
contract manufacturing globally. In September 2014, for instance, EPIRUS
Biopharmaceuticals (US) collaborated with Livzon Mabpharm (China) to
develop, manufacture and commercialise up to five biosimilar products.
Similarly, in May 2012, Coherus BioSciences (US) worked together with
Daiichi Sankyo (Japan) to develop and commercialise biosimilar forms of
Etanercept and Rituximab in certain Asian countries, including Japan.
Such strategic collaborations aid both partners, thereby generating high
returns on investment. This would also expedite clinical trial
activities that help to speed up the approval process and launch of
products.
Reference
1. Visit: www.research-in-germany.org/en/research-areas-a-z/ health-research.html
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