THE International Generic and Biosimilar Medicines Association (IGBA) is renewing its commitment to pushing for the establishment of worldwide biosimilar policies that deliver better health outcomes and biologics access equity for more patients.
The organisation has released a new paper, Embracing science with confidence: Adopting the revised 2022 World Health Organization (WHO) biosimilar guideline, to coincide with Global Biosimilars Week (14 to 18 Nov).
IGBA Biosimilars Committee Co-Chair, Julie Marechal-Jamil, said the paper aims to highlight the value of biosimilar medicines for patients, health professionals, governments and regulators.
"This paper highlights how the revised 2022 WHO Biosimilars Guideline provides clarity, consistency and confidence in state-of-the-art regulatory science for biosimilar medicines based on vast cumulated experience and over one million patient-treatment years of safety data in Europe alone," she said.
"We welcome this science-based evolution of the WHO guideline as a driver for efficiency gains in biosimilar regulatory processes which we know will have a direct impact on the ability of patients to benefit from timely access to biologic therapies."
IGBA Chair, Vivian Frittelli, added that national regulatory authorities now needed to re-examine their requirements to boost biosimilar use around the world.
"If cohesively adopted, the WHO Guideline can promote efficient regulatory systems to provide patients with earlier access to safe, effective, quality-assured, and lower-cost biosimilar medicines," Frittelli said.
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