Positive EMA opinions could bode well for US approvals of biosimilars

In our weekly expert view piece, Stacie Ropka, an IP attorney, and William Rose, an associate, from Axinn Veltrop & Harkrider, examine the biosimilar approval process in the EU compared to the US.

When the European Medicines Agency (EMA) issues a positive opinion for the marketing authorization of a biosimilar product, that opinion is then referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union (EU).  Although there are some key differences in approval requirements between the EMA and the US Food and Drug Administration (FDA), EMA approval of a biosimilar product could bolster the biosimilar applicant’s efforts at obtaining approval in the US.

Prior EMA approval is advantageous for receiving FDA approval