Growth forecasts for the global biopharmaceuticals market vary, but headline figures of close to USD 300 billion by the year 2021, rising from an estimated value of around USD 192 billion in 2016, are typical. Furthermore, as patents on large molecule therapeutics expire, and in a regulatory environment that encourages the development of ‘generic’ versions, the market share attributable to biosimilars is expected to increase rapidly. Recent FDA Guidance to Industry sets out an abbreviated licensure pathway for biosimilars, focusing on therapeutic protein products. Dr Lisa Newey-Keane, Life Science Sector Marketing Manager at Malvern Instruments, looks into the stability of biosimilars.

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