Biologicals

Similar biotherapeutic products

Control of chronic diseases is a major challenge for public health systems in both developed and developing countries. Biotherapeutic products have been successful in treating many life-threatening chronic diseases. However, the cost of innovative biotherapeutics has often been prohibitive, thereby limiting their use, particularly in developing countries.

The expiration of the patents and/or data protection for the first major group of originator's biotherapeutic products such as insulin, human growth hormone and erythropoietin has ushered in an era of products that are designed to be 'similar' to a licensed originator products. This is expected to contribute to increased access to these products at an affordable price.

The clinical experience and established safety profile of the original products should contribute to the development of similar biotherapeutic products (SBPs). The amount and extent of data required for the licensing of SBPs are likely to be less than are normally required for the originator products. However, a generic approach as applied to small – molecule pharmaceuticals is not appropriate for biological substances due to their complexity and the fact that clinical performance depends critically on the production process. Therefore, at the level of quality, data on the comparability of a new product with an established innovator, showing that they are “highly similar “, can be considered as additional data, over and above what is normally required for the originator product developed as a new and independent product; this is the basis for reducing the requirements for nonclinical and clinical data.

In addition, it is important to note that a biotherapeutic product that is not shown to be similar to the original product, i.e. its reference biotherapeutic product as indicated in WHO guidelines, should neither be described as "similar" nor called SBP.

Similar Biotherapeutic Product Standardization

Written Standards

Reference materials

WHO international standards/reference materials have distinct and important roles to play in the development and characterization of similar biotherapeutic products. The intended purpose of these materials is described in the following article:
R. Thorpe, M. Wadhwa/biologicals 39 (2011) 262-265.

Implementation

WHO Guidelines on adopted by the ECBS 2009 have been instrumental in raising awareness of the complex scientific issues related to the licensing of similar biological products. Implementation of the guidelines has become an increasingly important tool in achieving regulatory convergence.

The first workshop on Implementing "WHO Guidelines on Evaluating Similar Biotherapeutic Products (adopted in 2009)" into the regulatory and manufacturers practice at the global level was held on 24–26 August 2010 in Seoul, Republic of Korea. The workshop featured speakers from regulatory agencies from various countries, clinical and scientific experts, representatives from the biopharmaceutical industry and WHO. As the outcomes of the workshop, 26 peer reviewed manuscripts have been published as a special issue in Biologicals in September 2011. The online published articles in this issue are freely accessible to the public at the link below:

Meeting Reports

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Last update:

13 January 2014 15:58 CET