WHO calls for better science-based regulations for biosimilars

Home/Policies & Legislation | Posted 13/06/2014 post-comment0

The sixty-seventh World Health Assembly (WHA) of the World Health Organization (WHO) closed on 24 May 2014, after adopting more than 20 resolutions on public health issues of global importance, one of which calls for better science-based regulations for biosimilars.

Regulation V13H16

Resolution WHA67.21 on access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy, urges Member States:

  • To develop or strengthen national regulatory assessment and authorization frameworks, to meet the needs for biologicals, including biosimilars
  • To develop the necessary scientific expertise to facilitate development of solid, scientifically-based regulatory frameworks that promote access to products that are affordable, safe, efficacious and of high quality
  • To ensure that new national regulations do not create barriers to access to quality, safe, efficacious and affordable biologicals, including biosimilars

The resolution comes as a result of the fact that WHO acknowledges that biosimilars ‘could be more affordable and offer better access to treatments of biological origin, while ensuring quality, safety and efficacy’.

Generics and biosimilars advocate the European Generic medicines Association (EGA) welcomed WHO’s resolution on access to biologicals and biosimilars. EGA’s Director General, Mr Adrian van den Hoven, commented that ‘these resolutions constitute important milestones for patients worldwide as they aim to support national drug regulatory authorities, particularly in developing countries, to strengthen their regulatory systems, while promoting equitable access to quality, safe, efficacious, and affordable medical products.’

Related article

Global guidelines for biosimilars

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Source: WHO

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