The new multidisciplinary measure aims to address the factors relevant to assessing the need for comparative efficacy studies in the development of biosimilars, incorporating recent scientific advances.
PróGenéricos, an entity representing the generic and biosimilar drug industry in Brazil and a member of the International Generic and Biosimilar Medicines Association (IGBA), expresses its full support for the new Multidisciplinary Guideline announced at the last meeting of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), held in Madrid, Spain.
Based on analytical advances, nearly three decades of regulatory experience, and established guidelines such as the ICH Q5E Guide, the new guideline seeks to determine the usefulness of comparative efficacy studies in biosimilar development programs. In this sense, it aims to reduce the requirements for these studies when they are not decisive for regulatory decisions.
The initiative was endorsed by the IGBA, a member of the ICH, which highlighted the direct benefits in terms of cost reduction and increased global access to high-quality, safe, and effective biological therapies. “Comparative efficacy studies lack scientific value and offer no additional benefit to regulatory agencies or healthcare professionals. Robust regulatory science supports the development of biosimilars based on analytical data and a clinical pharmacokinetic study that includes safety and immunogenicity. Consistent, science-driven decisions for all biologics are critical to ensuring access to high-quality, safe, and effective medicines, as well as confidence in them," added Gillian Woollett, chair of the IGBA Biosimilars Committee.
For PróGenéricos, the decision is a strategic step toward more modern regulation, based on robust science and aligned with real public health needs.
“By reducing the requirement for comparative efficacy studies for biosimilars, the guideline promises to optimize the development of these drugs. With Anvisa already leading the way with an advanced regulatory framework, the guideline should strengthen the sector's growth in Brazil, positioning the country as an attractive hub for interest, development, and production of these drugs," says Tiago de Moraes Vicente, CEO of PróGenéricos.
With the proposed harmonization, it is expected that more countries will adopt convergent, science-based regulatory criteria, directly benefiting millions of patients around the world.
PróGenéricos reinforces its commitment to collaborating with regulatory agencies and other institutions to ensure that advances in the field of biosimilars result in greater access, more innovation, and better health for all.
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