Biosimilar Products: The challenges and growth prospects in the Ireland Pharmaceutical market.
Biosimilar products are the biological products which are very similar to and has clinical differences from an existing approved drug. An interchangeable product is also part of biosimilar products that fulfils the extra criteria of producing the same clinical results that of the reference product to any given patient (U.S. Food and Drug Administration, 2017). The approval process for the biosimilar product is the same as the other biological products, these products should be in conformance to standards prescribed for quality, safety and efficacy. The European Medicines Agency has implemented stringent approval mechanism to ensure the safety the products, so far there are 39 biosimilar products are approved by the EMA in the European Region (European Medicines Agency, 2018).
Biological products have gained importance due to high clinical success rate compared to the other pharmaceuticals product. A study conducted by DiMasi et al states that the overall clinical success rate of biological products is around 30.2% whereas the success rate of other pharmaceutical products is only around 21.5%. At the same time, there is no conclusive evidence regarding the huge difference in R&D costs for the biological products when compared with the other pharmaceutical products (Mestre-Ferrandiz, et al., 2012, p. 71)
One of the critical success factors in the biosimilar drug development program is to utilize the regulatory requirements imposed by different countries in regulating the manufacturing and marketing of biosimilar products. The advanced markets for pharmaceuticals such as the European Union, USA, and Japan have already issues the regulatory policies whereas the emerging countries are following the WHO guidelines for the manufacturing and licensing (Goblar, 2010, p. 7).
The Republic of Ireland is lagging in terms of biosimilar use in the European Union. The National biosimilar policy is yet to be finalized by the Department of Health (DOH). The DOH has started the consultation process with the various stakeholders, a recent consultation occurred in September 2017. The Republic of Ireland has underlined the benefits of introducing biosimilar products in the Ireland to reduce the overall cost of the healthcare. It is noted that a price decrease of 30% in the biopharmaceuticals products when a similar new biosimilar product is introduced in the market. The National Biosimilar policy is expected to increase the market share of the biosimilar products in the Irish market, the current market share of 0.2% is expected to exponentially when the new policy is authorised (Generics and Biosimilar Initiative, 2018).
Aims and Objective
The objective of this study is to comprehend the challenges faced by the biosimilar products while entering the pharmaceutical market and the growth prospects in the Ireland pharmaceutical market. The status of the Irish market for biosimilar is unimpressive as the market share of 0.2% indicates, the status is expected to improve once the national policy is framed and when the influential stakeholders contribute to the growth.
The aim of the study is to understand the reasons, challenges, and growth opportunities from the pharmaceuticals that are operating in the Ireland region. The research outcome will provide an insight to the root cause for the current status and expected growth in future.
The research will be part of the applied research category since the research objective is to answer a practical problem. The quantitative methods will be used to collect and analyze the data.
The secondary data will be collected from the market research reports published in the pharmaceuticals journals, and other industry related databases. The secondary data will also be referred from the academic research which already conducted related to this topic.
The primary data will be collected through questionnaires from the industry experts in the Ireland. The questionnaires will be administered both online and in person based on the requirements.
The probability sampling design will be used as the total population of the Irish biopharmaceuticals can be taken from the industry records. The random sampling techniques to be used to identify the samples and a minimum of 50 samples will be selected. The questionnaire will be sent to the executive level employees in the biopharmaceuticals company to understand their perspective. The executive level employees will be in a great position to answer to the research question.
The cross-sectional research design will be applied since the data and research will showcase the challenges and issued faced at a specific point in time.
There is a limited information available in the literature about the biosimilar products in Ireland market. However, there are few interrelated researches are conducted in the past. The literature review section narrates the existing knowledge available regarding the research subject.
Literature Review one - Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland
The Study conducted with an objective of understanding the awareness about the biosimilar products in the Ireland. The study reveals that the majority of the medical specialists and pharmacists aware about the existence of the biosimilar products however most of the general practitioners not even aware of the existence of the biosimilar products. The healthcare professionals also not aware of the difference between biosimilars and generic drugs.
The research proves that healthcare professionals needs to be educated with the benefits of biosimilars so that they can prescribe these products to the customers. The understanding level of the healthcare professionals about the biosimilar product is an indirect cause for the low market share in Ireland.
Literature Review Two - Biosimilars in Brazil: Developments in 2015 and Business Perspectives
The report underlines the state of biosimilar product licensing procedure and overall state of biosimilar market in Brazil. The report states that the first biosimilar product in Brazil was approved in 2015, and Government of Brazil has launched a program called Parcerias paro Desenvolvimento Productivo to cut down the public health deficit.
The Irish market strategy can be benefited from the Brazilian market as the both the markets are relatively new for the biosimilar products.
Scope and Limitation
The scope the research is restricted to the biopharmaceutical companies based out of Ireland.
The access to information is the primary limitation to conduct the study. The cost and time available to complete the study are secondary limitations for the successful completion of this study.
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