According to the new whitepaper Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline from the International Generic and Biosimilar Medicines Association (IGBA), the framework provides a fantastic opportunity to re-evaluate how regulatory standards can better progress biosimilar access.
IGBA claims that by authorising high-quality, secure, and effective biosimilar medications for patients who would not otherwise have had access to them, the World Health Organization (WHO) Biosimilars Guideline has been a valuable tool for health authorities to boost global regulatory integration and consistency of terminology when assessing biosimilars.
The guideline underwent significant modifications in 2022, including a limited, exception-based approach to animal research, a streamlined method for taking needs for clinical comparability into account, and a simpler method for locating comparator items.
According to Julie Maréchal-Jamil, Co-Chair of the Biosimilars Committee, this study summarises how the amended 2022 WHO Biosimilars Guideline provides clarity, continuity, and self-belief in state-of-the-art regulatory science for biosimilar medicines based on experience and over 1 million patient-treatment years of safety information in Europe alone. They welcome this scientific evolution of the WHO guideline as a catalyst for efficiency improvements in the regulatory processes governing biosimilar products. According to the recommendation, comparative effectiveness and safety trials will not be required if adequate proof of biosimilarity can be obtained from other components of the comparability exercise, which was underlined in the report.
Assuring regulatory authorities that using a non-locally authorised reference product as a comparator for biosimilar development will be successful, the document also stated that the guideline’s suggested move forward into broad acceptability of a non-local benchmark will decrease the need for copied development steps, including clinical studies, and help speed up the availability of biosimilar medicines.
At this point, the national regulatory agencies must quickly review their standards. The WHO Guideline can support successful regulatory systems to give patients earlier access to reliable, efficient, quality-assured, and less expensive biosimilar medicines if it is applied consistently, said Vivian Frittelli, IGBA Chair.
Access possibilities in significant policy areas produced by the IGBA blueprint
The IGBA’s 2021 Biosimilar Medicines Access Policy Blueprint, which sought to improve regulatory efficiency for broader access, included biosimilars access as one of four important topics.
Increasing Access and Regulatory Efficiency
International convergence: streamlined regulatory process timelines, the elimination of diverse local data requirements, and convergence of guidelines and evidence requirements
Worldwide development: simplifying clinical development and recognising global comparable products
Worldwide Reliance: Implementing the guidelines (for example, through training), organising and recognising facility inspections, incorporating the WHO process for the availability of quality-assured biosimilars, and maintaining the WHO listed authority approach.
Other crucial aspects:
- Increasing market resilience and predictability through fast and reliable access
- Modifying co-payment and reimbursement procedures to ensure inexpensive access
- Promoting knowledge and confidence in biosimilar medications through continuous access
The release of the IGBA’s whitepaper coincides with the third Global Biosimilars Week, which takes place from November 14–18, 2022. Under the hashtag #globalbiosimilarsweek, the organisation invites stakeholders from all over the world to exchange thoughts, insights, and resources with the rest of the world’s healthcare professionals. For patients, health professionals, clinicians, authorities, healthcare systems, and legislators, the campaign’s theme is strengthening healthcare and the value of biosimilar medicines.