The race in biosimilar development is becoming more competitive – and crucial – by the day. The National Center for Biotechnology Information estimates that $100 billion (USD) in biologic drug sales will lose patent protection by 2020.

This projection, combined with global public healthcare budget cuts and advances in biologic manufacturing technology, is creating an intensely competitive marketplace.

Biosimilar drug development presents a host of challenges – constantly evolving global regulatory pathways, and the necessary optimisation of clinical development plans in order to not only gain approval, but to also achieve the ultimate goal of gaining market share.

This article focuses on one specific aspect of biosimilar development: How do we access the reference drug?



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