Abstract
<p>A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product). A biosimilar demonstrates similarity to the reference biological product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise. EMA (European Medicines Agency) was the first to introduce the guidelines for biosimilar approval, effective from June 2006. Biosimilar guideline was released in 2010 in Brazil and 2012 in India. Recently China published its guideline for biosimilar approval in 2015.</p><p>This article summarizes the regulatory requirements for approval of biosimilars in India, Europe, Brazil, and China. These countries require comparability exercise of a biosimilar with reference biological product for generating comparative analytical, non-clinical and clinical data (usually one or two phase 1 and phase 3 comparative studies). A case study of infliximab biosimilar approval in India, Brazil and Europe has also been included.</p>
Highlights
European nations are the biggest market for biosimilars, followed by Asia-Pacific countries with, China and India expected to grow at the fastest rate
The similarity to reference medicinal product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise must be established
The standard generic approach which applies to most chemically-derived medicinal products is in principle not appropriate to biological/biotechnology-derived products due to their complexity
Summary
European nations are the biggest market for biosimilars, followed by Asia-Pacific countries with, China and India expected to grow at the fastest rate. Establishing similarity between biosimilar and reference biological requires comparison of quality characteristics that will lead to the reduction of non-clinical and clinical data needed for the approval process. Biosimilars need to establish similarity to the reference product in terms of quality, non-clinical and clinical studies. Regulatory requirements for marketing authorization of similar biologic in India were released in 2012 and require extensive quality/analytical comparative data in addition to abridged clinical/non-clinical studies are required for biosimilar approval. The similarity to reference medicinal product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise must be established. The infliximab biosimilar (Remsima) was approved by EMA (European Medicines Agency) for all indications for reference biologic on the basis of submitted clinical data for rheumatoid arthritis and ankylosing spondylitis. Phase III study One Phase III randomized, double-blind, active comparator study (in India) to compare efficacy and safety of infliximab biosimilar (n=127) with Remicade (62) with severe, active rheumatoid arthritis on stable doses of methotrexate in 189 patients with rheumatoid arthritis taking methotrexate
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