Regulators Highlight Differing International Biosimilar Regulations; Interchangeability Guidance May Slip to 2017

Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Interchangeability  •  Regulatory Guidances

Bloomberg BNA reported that a panel of regulators at the DIA 2016 Biosimilar Conference in Washington highlighted the differences among biosimilar regulations internationally and the ongoing changes as countries revise their biosimilar guidances.

For instance, in Canada, biosimilars are regulated as new biologics as opposed to the U.S.’s abbreviated pathways under the BPCIA.  Bloomberg also reported that European regulators described the EMA’s biosimilar guidances as “living documents” that are subject to regular revision.

Interestingly, Bloomberg reported that the FDA’s representative said the FDA “cannot commit” to issuing draft interchangeability guidance by the end of the year.  This stands in contrast to reports only a few weeks old that the FDA would indeed release the long-awaited draft guidance this year.

As always, continue following Big Molecule Watch for updates on biosimilar practices and regulations as they happen.

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