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The potential demand for biosimilars undoubtedly generates an enormous opportunity for biopharmaceutical companies. However, biosimilar development and commercialiszation is an inimitably complex endeavour requiring a precise, stepwise strategy to ensure timely regulatory approval and optimum market access. Even companies that are aiming to protect the market share of a branded biologic product are compelled to adapt to the increased competition from biosimilars. Given these dynamics, the uniqueness of biosimilars necessitates that an integrated, strategic development and commercial plan must be shaped in the very initial stages of any biosimilar development program to keep the momentum.

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