Streamlining biosimilar development: the regulatory landscape, past, present and future perspectives


What are biological medicines?  Biological medicines contain active substances from a biological source, such as living cells or organisms (human, animals and microorganisms such as bacteria or yeast). These medicines include but are not limited to recombinant therapeutic proteins, vaccines, blood and blood components and gene therapies.    A biosimilar medicine is a biological medicine developed to be highly similar to an originator (the ‘reference product’). Importantly, the approval process for biosimilars requires the same standards of pharmaceutical quality, safety and efficacy that apply to any and all biological medicines so biosimilar medicines are as safe and efficacious as their corresponding reference product. Biological...

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