Health care systems globally face many challenges, including rising costs and uneven access. One potential solution is biosimilar medicines. These drugs can improve access to affordable care, aligning with the United Nations’ Sustainable Development Goals for Health by 2030. Let’s dive deeper into how biosimilars can help achieve this vision.
The sixth Annual Global Biosimilars Week takes place from November 3 to 7, 2025, focusing on the theme “Biosimilars: A Wise Investment for Global Health.” This theme highlights both the importance and potential of biosimilars in health care.
Several experts participated in a recent webinar on this topic:
- Skylar Jeremias, from The American Journal of Managed Care
- Julie Maréchal-Jamil, from Medicines for Europe
- Helen McGuire, from PATH Coalition
- Navin Kumar Loganadan, clinical pharmacist in Malaysia
- Socorro Márquez, regulatory affairs expert at Sandoz Mexico
- Aurelio Arias, from IQVIA
- Paul Cornes, MD, oncologist in the UK
- Lisa Hedman, senior advisor at the World Health Organization (WHO)
During the discussion, the speakers addressed audience questions about the impact of biosimilars on global health. For example, Julie Maréchal-Jamil pointed out that successful examples of improving access can be found in the IGBA Biosimilar Access Policy Blueprint. Effective policy frameworks are crucial for translating cost-efficiency into better resource use.
A 2024 WHO report indicates that the goal is to have 80% availability of off-patent medicines, including biosimilars. While progress has been made, it’s uneven—varying from 38% to 68% in public sectors and showing higher availability in private sectors, from 42% to 77%. High prices and out-of-pocket payments remain significant barriers, particularly for countries facing economic challenges.
In Mexico, current regulations require clinical trials for biosimilars. These “biocomparables” must undergo specific evaluations, which can vary based on guidelines from local authorities. Understanding this regulatory landscape is essential for manufacturers planning to enter the market.
Regulatory convergence among agencies like the FDA and EMA aims to streamline the approval process for biosimilars. This development would greatly impact costs and timelines. However, companies may still need to conduct new studies, which might prolong market entry.
Amid these regulatory changes, ensuring sustainability in the biosimilars market is crucial. Fast drops in prices could threaten the viability of biosimilar manufacturers. As Maréchal-Jamil noted, market dynamics will heavily influence the industry’s health. Increased competition and broad usage of biosimilars are key factors in the market’s success. Moreover, initiatives like the African Continental Procedure could boost regional access to biosimilars, which could improve overall health outcomes.
However, there’s a notable lack of visibility into the real-world benefits of biosimilars. While many studies showcase their clinical effectiveness, fewer health systems publish data on increased access or reinvestment of savings into care. Encouraging transparency in data sharing from health systems could strengthen confidence in biosimilars and promote their use.
To summarize, biosimilars present a viable option for improving health care access and affordability worldwide. However, sustained effort in regulation, pricing, and transparency will be essential to unlocking their full potential.
For more insights on biosimilars and health care access, visit the IGBA Biosimilars Clinical Trial Policy Paper and find valuable resources on WHO’s initiatives regarding biosimilars.
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