IGBA reiterates its yearly call to join the biosimilars movement on advancing access

In the week ahead, IGBA will renew its commitment to the collaborative effort to establish worldwide biosimilar policies that deliver better health outcomes and biologics access equity for more patients. The third Global Biosimilars Week will run from 14th to 18th November, 2022 on social media, supported by a rich resource dedicated website globalbiosimilarsweek.org.

This awareness campaign is open to all stakeholder contributions worldwide and seeks to release and gather, under one hashtag #globalbiosimilarsweek, useful ideas, experience, interviews, information and resources for and from patients, doctors and all other stakeholders across the global healthcare community. The campaign theme this year is Strengthening Healthcare | The value of biosimilar medicines for patients, healthcare professionals, providers, governments and healthcare systems, as well as regulators.

The IGBA takes therefore the opportunity to release its new White Paper, entitled Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline. This paper, developed by the IGBA Biosimilars Committee, further elaborates on one of the four key areas identified in the IGBA’s 2021 Biosimilar medicines Access Policy Blueprint, namely enhancing regulatory efficiencies for greater access.

“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 1 million patient-treatment years of safety data in Europe alone”, explained Julie Maréchal-Jamil, Co-Chair of the Biosimilars Committee. “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, “ she added.

“Now we need the national regulatory authorities to promptly re-examine their requirements. 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,” concluded Vivian Frittelli, IGBA Chair.

IGBA companies are the pioneers and global leaders in the development and marketing of biosimilar medicines. To date there have been 600 biosimilar approvals in IGBA’s membership jurisdictions plus Singapore and Switzerland, covering more than 10 therapeutic areas including oncology, rheumatoid arthritis, psoriasis, inflammatory bowel disease, growth disorders, nephrology, fertility, diabetes and ophthalmology.