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biosimilar-approvals-and-launches-2021

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Insights into some of the Biosimilar Drugs that are approved and launched in 2021

Since the first biosimilar drug was approved in 2006, the EU has led the way in biosimilar regulation. Over the last decade, the EU has authorized the most biosimilars globally, gathering significant expertise with their usage and safety. Over ten years of clinical experience has shown that biosimilars licensed by the EMA may be used as safely and effectively as other biological medicines in all of their approved indications. On the contrary, the biosimilars market in the United States has previously been described as sluggish. Patent litigation and thickets, anti-competitive settlements, and the period required from FDA clearance to market launch are barriers to bios...

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