?? Strong market growth driven by rising healthcare demand and need for cost-effective biologic treatments

?? Increasing approvals and availability of biosimilars for oncology, autoimmune, and chronic diseases

?? Expanding support from government policies and healthcare providers to enhance biosimilar adoption and accessibility

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Mexico Biosimilar Market Trends and Drivers:

Mexico’s biosimilar market is going through a major shift, thanks to recent regulatory changes by COFEPRIS (Federal Commission for Protection against Health Risks). In 2023, the agency introduced new approval guidelines that align with international standards, including those from the EMA and FDA. These updates have cut the average approval time for biosimilars in half—from 36 months to about 18 months. As a result, the start of 2024 saw the launch of 12 new biosimilar drugs, particularly for cancer and autoimmune conditions like trastuzumab, rituximab, adalimumab, and infliximab. Both local firms like Probiomed and Landsteiner, and global players such as Biocon and Celltrion, are helping expand treatment options.

Even though biosimilars typically cost 25–35% less than the original biologic drugs, pricing remains a concern for some. However, the expiration of patents on key drugs like insulin glargine and etanercept is expected to boost the use of biosimilars going forward. That said, there are still hurdles, especially when it comes to tracking side effects and ensuring proper monitoring through Mexico’s healthcare systems.

One of the biggest drivers of growth has been demand from the public health sector. Government-run programs like IMSS and INSABI have significantly increased biosimilar usage, with biosimilars making up about 43% of all biologic medications dispensed in early 2024—up from 28% just two years ago. This growth is being driven by rising rates of chronic conditions like diabetes, which affects around 17% of adults, and nearly 190,000 new cancer cases diagnosed each year. Still, access to these medicines isn’t equal across the country. While city hospitals often include biosimilars in up to 95% of their treatment options, rural areas continue to struggle, largely due to limited logistics infrastructure, like cold-chain storage.

In the private healthcare system, biosimilars are gaining ground more slowly, accounting for about 22% of prescriptions. However, policies like step-therapy protocols are starting to help. For example, the inclusion of biosimilars for rheumatoid arthritis under the expanded Seguro Popular program reflects growing support from healthcare policymakers. But with over a third of Mexican households still facing high out-of-pocket medical costs, affordability remains a significant issue.

On the production side, Mexico is making strides. Foreign investment and government incentives have led to growth in local maContact Us:

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