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  • Existing regulatory approval pathways for generic medecines do not apply to the approval of biosimilars or SBPs due to their complexity.  The use of the terms “biogenerics” or “generic biologicals” for these medicines is therefore incorrect.  Unlike generic medicines, biosimilars are seldom the same as their reference products. 
  • Similarity between a biosimilar and its reference biotherapeutic product should be evaluated in all respects (quality, safety and efficacy).  Purported copies of biotherapeutic medicines that have not undergone head-to-head comparisons with an appropriate reference product put patient safety at risk and should not be licensed via biosimilar pathways.

Background

Biotherapeutic medicines are therapies derived from living organisms that are used to treat complex, serious illnesses such as cancer and diabetes.  They are generally large and highly complex proteins that are fundamentally very different from synthetic molecule medicines, which are much smaller and simpler in structure.

In the majority of cases, these novel medicines, which are the result of years of pioneering research and complex manufacturing processes, are no longer protected by patents and therefore create the opportunity for the introduction of similar biotherapeutic medicines by other companies.  The global market is expected to increase to $3.7 billion by 2015 as more patents expire. (ii)

Because many characteristics of biotherapeutic medicines are unique to and dependent on a specific manufacturing process, biosimilar products can only demonstrate similarity to a reference biotherapeutic product rather than produce an identical replica.  In 2006, the European Medicines Agency was one of the first regulatory authorities to develop guidelines and create standards for licensing biosimilars in the European Union (EU).  They were closely followed by Malaysia in 2008 and Canada in 2010.  Many other national authorities are currently investigating the development of national regulatory pathways for biosimilar registration.

The World Health Organization (WHO) published its “Guidelines for the evaluation of similar biotherapeutic products (SBPs)” in 2009.  The purpose of this guideline is to provide an international norm for evaluation that focuses on biosimilars having a high degree of similarity with regard to quality, safety and efficacy to an already licensed, reference biotherapeutic medicine.  The implementation of this guideline is an ongoing process in many countries, and the IFPMA is committed to working with all stakeholders to support science-based legal and regulatory frameworks at the national level.

Purported copies of biotherapeutic medicines that have not undergone head-to-head comparisons with their respective reference product put patient safety at risk.  These products are not true biosimilars. The differences between the reference biotherapeutic product and the intended copy must be understood, quantified, and sufficiently studied to ensure that it does not show any clinically-meaningful differences before it achieves marketing authorization as a “biosimilar”.

(i) WHO.  Guidelines for the evaluation of SBPs – Oct. 2009.
(ii) Reuters.  Drugmakers gear up to copy biotech drugs in US – May 2011.

The World Health Organization describes biosimilars (which they refer to as Similar Biotherapeutic Products (SBPs)) as “a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product”. (i)

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