After years of legislative roadblocks and slow delivery of regulatory guidance, the world’s largest biologics market, the United States, is finally open for business to biosimilars with the entry of Zarxio (biosimilar of Neupogen) and the approval of Inflectra (a biosimilar of Remicade).

With the arrival of the first biosimilar in the US market, some preliminary questions have been answered, but critical questions remain unanswered for biopharmaceutical manufacturers.

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