Ensuring Effective Safety & Risk Management for Biosimilars

Pharma BioWorld
June 2015
Suhasini Sharma, Sciformix Corporation

Biologics have made great contributions to the treatment of many diseases including cancers, and are expected to provide significant therapeutic benefits to many patients. However, due to their unique source material and complex manufacturing processes, biologics are very expensive, making them unavailable to a large number of patients. Moreover, many biologics are still under patent – contributing to their high price. This scenario is soon to change. It is estimated that around two dozen biological products with global sales of more than USD 67 billion will go out of
patent by 2020.1

End of patent exclusivity and advances in biotechnology facilitating their manufacture have opened up huge opportunities for follow-on biosimilars. IMS Health forecasts that the global biologics market will reach USD 250 billion by 2020, and biosimilars and non-original biologics will represent 4-10 per cent of that market.2 The price of a biosimilar is on an average between 10 and 35 per cent lower than the respective reference product.3 Therefore, growth in biosimilars will drive down healthcare costs and generate significant savings for healthcare systems.

Biosimilars, unlike generic chemical drugs, are similar but not exactly identical to the reference products, and this poses multiple challenges in their development, safety monitoring and regulatory approval process.

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