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The development of biosimilars signifies a pivotal advancement in biologic treatments, driven by the expiration of patents on original biologics and the need for more cost-effective options. Biosimilars undergo rigorous development processes to ensure they closely resemble their reference biologics in terms of safety, purity and potency, despite the complex nature of biologic production preventing them from being identical. This review delves into the thorough analytical, preclinical and clinical evaluations necessary for biosimilar approval, emphasizing the importance of comprehensive comparability studies. It addresses significant challenges such as manufacturing complexities, immunogenicity, post-marketing surveillance and interchangeability issues. Despite these challenges, biosimilars offer significant cost savings and improved patient access to biologic therapies. Taking a multidisciplinary approach, this article provides guidance on the clinical use of biosimilars, emphasizing their potential to sustain healthcare systems while upholding patient safety and treatment efficacy.
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