WHO Will Hold Off on Using Biological Qualifiers for Biosimilars

Regulatory NewsRegulatory News | 19 October 2017 |  By 

No consensus has been reached on whether the World Health Organization (WHO) should continue with its biological qualifier proposal in assigning international nonproprietary names for biosimilars, and WHO says it "will not be proceeding with this at present," according to an October report.

The US Biosimilars Council praised the WHO move, which follows the US Food and Drug Administration’s (FDA) use of a system in which biosimilar nonproprietary names come with a four-letter suffix to distinguish them from their reference products, which is similar to what WHO had proposed.

In addition to the work on the biological qualifier at WHO’s meeting in May in Switzerland, WHO decided to move forward with a pilot project on the pre-qualification of two biosimilars of rituximab and trastuzumab.

"Drawing on international experience with Stringent Regulatory Authorities (SRAs), two pathways, one based on [biosimilars] SBPs with SRA approval and the other without, are being considered. The pilot is aimed to investigate how SBPs can go through the [prequalification] PQ process and how PQ listing can contribute in improving access," the report says.

Key challenges highlighted at the meeting included "encouraging trust" in biosimilars and developing and sustaining a market that "balances the interests of pharmaceutical companies and the need for patient access to quality therapeutics."

The topic of interchangeability was also addressed at the meeting and "it was suggested that if high quality, safe and effective SBPs are available, there will be less concern about interchangeability."

Suggestions were also floated on compiling a list of interchangeable biosimilars to help countries select what is best for them, though it was recognized "that opinions on interchangeability are not going to change overnight."



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