NHS England's Biosimilar Transition: A Cautionary Tale for Patients and Investors

NHS England's cost-saving strategy to transition multiple sclerosis (MS) patients from Biogen's Tysabri to Sandoz's biosimilar Tyruko has sparked alarm as patients report severe side effects. This shift, aimed at reducing healthcare costs, has raised concerns about the safety and efficacy of biosimilars, as well as the role of regulatory bodies in ensuring patient protection.

The transition, driven by the expiration of Tysabri's patent and the introduction of cheaper biosimilars, has led to significant side effects for some patients. At Charing Cross Hospital in London, around 170 MS patients experienced complications, including relapses, mobility issues, fatigue, pain, and weight gain, after being switched to Tyruko. Some cases were severe enough to require hospitalization (The Guardian, 2025).

NHS England and Sandoz have both acknowledged the reports of adverse reactions and are investigating the issue. However, the incident has raised questions about the safety and efficacy of biosimilars, as well as the role of regulatory bodies in ensuring patient protection.

Regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) play a crucial role in approving and assessing the cost-effectiveness of new medicines, including biosimilars. However, their processes can be improved to better protect patients:

1. Enhance transparency and communication: Regulatory bodies should improve transparency in their decision-making processes and communicate more effectively with healthcare professionals, patients, and caregivers about the approval process, potential side effects, and ongoing safety reviews.
2. Strengthen collaboration: The MHRA and NICE should collaborate more closely to ensure that safety, efficacy, and cost-effectiveness are all considered in the decision-making process. They could work together to develop clearer guidance for healthcare professionals and patients on the use of biosimilars.
3. Continuously update guidelines and standards: Regulatory bodies should keep their guidelines and standards up-to-date with advancements in biosimilar technology and the evolving landscape of healthcare.

In conclusion, NHS England's transition from Biogen's Tysabri to Sandoz's Tyruko has highlighted the potential risks and benefits of biosimilars, as well as the importance of regulatory bodies in ensuring patient safety and efficacy. As the use of biosimilars continues to grow, it is crucial for regulatory bodies to enhance their processes, collaborate more effectively, and communicate more transparently to better protect patients and ensure the safe and effective use of biosimilars.