Abstract
The World Health Organization has provided specific guidance for biosimilar products to assist regulators, manufacturers and other professionals involved in the development and evaluation of these products. The development and approval of biosimilars are important for health care, as they allow the marketing of safe, efficacious and affordable biological products. Since the first biosimilars were approved in the EU in 2006, a series of biosimilars have been approved in many countries/geographical regions. This manuscript provides the figures on the status of approved biosimilars in 16 countries based on the information from regulatory experts and from publicly available data. It is clear that increasing numbers of biosimilars are now available in many countries and provide more options for treatments. It is expected that adoption of biosimilars will allow affordable health care and greater patient access to important medicinal products. It will also contribute to the overall WHO goal recognized by the World Health Assembly in 2014 by adopting a resolution on access to biotherapeutic products including biosimilars and on ensuring their quality, safety and efficacy.
Highlights
Development of biosimilars is important for health care as it allows the marketing of safe, efficacious and affordable biological products
Has organized a number of implementation workshops to assist regional regulatory agencies and manufacturers in the biosimilars area. As part of these workshops, surveys have been conducted to understand the current situation with biosimilars in the participants’ countries [1, 5, 6]. These surveys provide a unique opportunity to establish the situation with currently marketed biosimilars/similar biotherapeutic products in 16 countries
The information contained in this survey report is from participants of 15 countries who agreed for their information to be disclosed
Summary
Development of biosimilars is important for health care as it allows the marketing of safe, efficacious and affordable biological products. WHO has organized a number of implementation workshops to assist regional regulatory agencies and manufacturers in the biosimilars area. As part of these workshops, surveys have been conducted to understand the current situation with biosimilars in the participants’ countries [1, 5, 6]. These surveys provide a unique opportunity to establish the situation with currently marketed biosimilars/similar biotherapeutic products in 16 countries.
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