Regulatory Pathways Are Opening Up Globally for Biosimilars

Implementation of biosimilar legislation in India and Brazil, an increase in drug review staff in Japan, and the publication of a draft monograph for monoclonal antibodies to be included in the Chinese pharmacopeia are among the regulatory efforts taking place across the globe that expand the opportunities for biosimilars.

Brazil’s ANVISA is working to implement the biosimilar regulatory approaches it incorporated into guidelines in 2010.  The directives allow for two approval pathways – a comparability pathway and an individual development pathway – the eligibility for which will depend on how well-characterized the reference product is.

Under the less-rigorous comparability pathway, the sponsor needs to complete a full comparability exercise, covering the analytical, non-clinical and clinical aspects.  Only products following this pathway will be deemed “biosimilar” and interchangeable with the branded product.  ANVISA’s guidelines for comparability are based on the Health Canada and WHO guidelines.

In the individual development pathway, a reduced dossier can also be presented.  The applicant needs to provide complete data regarding quality issues, but unlike for new therapeutics, is only required to present comparative data for Phase 3 clinical trials.  This pathway requires more extensive clinical trials than the comparability route, and products approved will not be available for interchangeability or substitution.

To date, ANVISA has approved two biosimilars – copies of Roche’s Mabthera and Pfizer’s Enbrel – both used in the treatment of rheumatoid arthritis.

[CLICK HERE for the complete story.with insights from key health agency officials on biosimilars regulatory developments in Brazil, India, China, Japan, Canada and the US and EU.  Nonsubscribers can purchase the story for $195 by contacting Karen Bertani (  For subscription/license information, click here.]

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