Background: In order to establish safety and efficacy, generic medicines are required to prove bioequivalence with the innovator product while in case of Biosimilars (copy version innovator biologicals) requirements are product specific (case by case basis) and there is no common data requirement to establish the safety and efficacy. The challenge is to determine the nature of clinical and non-clinical studies required.
Methods: The major causes of variability are its large size, complicated structure, stability issues, microheterogeneity involved and manufacturing process, etc. It is also difficult to draw a common regulatory pathway which covers all possible complex products. So, in
this article we discuss the technicalities involved with this complex therapeutics (emphasizing on biosimilars) and look into regulatory frameworks for market authorization, keeping USFDA,
EMA and ICH guidelines as standards.
Results: Regulatory authorities have identified three main characteristics of a protein that must be considered during development i.e., 3D structures, post translational modifications (PTMs) and protein aggregation. Agencies generally consider the totality of the evidence to support a demonstration of biosimilarity, and recommend that sponsors should use a stepwise approach in the development of biosimilar products which may include a comparison of the proposed product and RBP with respect to Structure, Function, Animal Toxicity, Human Pharmacokinetics (PK) and Pharmacodynamics (PD), Clinical Immunogenicity, and Clinical Safety and effectiveness.
Conclusion: There is also ambivalence about its future market considering the complicated development process involved. Its market growth has been alluring for pharmaceutical companies so far. An in-depth understanding of science involved and technologies available to explore may lead us to an affable regulatory pathway. In this review we put an effort to touch upon these aspects of biopharmaceuticals.