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Biosimilars And Follow-On Biologics Market
Biosimilars is defined as a type of biological product that is similar to another drug, which has already been licensed (approved) by the US FDA or European Medicines Agency. Due to their high degree of similarity with the biological reference product, they have no clinically evidenced and meaningful differences from the reference product in terms of quality, safety or efficacy. These drugs are also coined as follow-on biologics and are mostly derived from biological sources such as bacterium and yeast. The constitution of the biosimilar drugs can be either small molecules such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies. Biosimilars are increasing gaining prominence given the loss of exclusivity of big branded drugs. In Europe, biosimilars can be marketed through independent applicant following expiry of patent and market exclusivity periods of the reference product. A good example for this is Pfizer acquisition of Hospira, to gain access to the latter’s attractive biosimilars portfolio. Regulatory harmonization, naming and labelling, innovative licensure norms and route to market for the biosimilar drugs are issues expected to gain attention and traction from big drug makers in the forthcoming years.
