Ensuring Patient Safety Considering Biosimilars and Bioequivalents Treatments

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What steps can be taken to ensure patient safety when considering biosimilars and bioequivalents as treatment options? While there are currently some regulatory guidelines for approving biosimilars, these may not be enough to guarantee their safety and efficacy. For example, studies have shown a risk of decreased efficacy and potential harm when switching from the reference biologic to a biosimilar (Kleppin, 2020). Therefore, it is important to consider how we can further ensure patient safety when using these types of treatments. Are more stringent guidelines needed for approval, or is there a more robust system that could provide more detailed information on the safety and efficacy of these medications?
Biosimilars and bioequivalents have the potential to offer a cost-effective alternative to expensive brand-name drugs. However, to ensure these medications' safety and efficacy, it is important to have a robust syste...