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International Clinical Trials

Growth Spurt

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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Rajveer Singh Rathor is Lead Analyst in Healthcare at MarketsandMarkets. With around six years of experience in healthcare market research and consulting in the pharmaceutical industry, he has worked on many projects in the pharma, healthcare, biotechnology and medical devices area to serve clients across the globe.
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