生物学药物（生物学）对治疗许多慢性和严重疾病（如癌症，慢性症）和一些罕见的遗传疾病的治疗做出了重大贡献，并预计将为许多患者提供有限的治疗方案。
Development of biosimilars or follow-on biologics is therefore an undeniable reality. However, biologics (other than blood products and vaccines) are relatively recent in origin and are beyond the reach of many patients due to their high price. Additionally, unlike a generic chemical drug, a follow-on biologic is similar but not exactly identical to the reference product, and this poses unique challenges in its development and regulatory approval process. Biological drugs are large therapeutic proteins and are enormously complex in structure. Their manufacture requires complicated biological production and purification processes in highly controlled environmental conditions and under strict quality controls. A slight difference in the biological starting material (such as a genetically modified cell line or organism) or a minor change in a step in the manufacturing/purification process can have a significant impact on the quality and purity of the product, and may result in a product with appreciably different characteristics and a variable efficacy and safety profile as compared to the reference innovator product.
药物知识是关键
由于它们对待的条件性质以及较少的患者在发育临床试验期间暴露于生物学的事实，后批准后药物可怜的药物可恶。此外，因为生物学是复杂的蛋白质，其可以保持在体内的较长并且通过生物途径进行修饰，所以分子的安全问题可能在可变时期中表现出可控制的临床试验的时间过程之外。因此，当首次批准时，生物学的安全性突破未完全阐明。
Since a biosimilar drug is not identical to the reference innovator product, the efficacy and safety data generated for the latter cannot be directly and completely transferred to the biosimilar. Both its efficacy in various therapeutic indications and its safety profile in diverse risk populations may be different from that of the innovator. Hence, compared to a chemical generic there is a bigger need for strict post-marketing product vigilance (including accurate identification of suspect product), and additional post-approval studies in the case of biosimilar products.
Additional risk management measures include following naming conventions to ensure traceability, having a product-specific risk management plan to address risks which may be different from those of the reference product, careful medical evaluation of all immunogenicity reports within the ‘risk window’, a product label with efficacy and safety information related to both reference and biosimilar product identified by source, and close post-approval monitoring of safety,
药剂纲素and risk management for biosimilars presents a number of unique and significant challenges. Routine PV processes may need to be adapted to address these issues. To learn more about these challenges and the possible solutions in safety monitoring and risk managementread this whitepaper.
