评估生物类似产品的结构和功能相似性:贝瓦西祖马布作为一个案例研究
Sanghati Bhattacharya1, Anurag S Rathore1
1Chemical Engineering Department, Indian Institute of Technology, Delhi, India.
概括
一项综合性研究比较了创新者贝瓦齐祖马布 (阿瓦斯) 与六种印度生物类似药. 大多数生物类药物表现出高度相似性,但有一种表现出关键质量属性偏差.
科学领域:
- 生物制药学分析分析
- 药物可比性研究 药物可比性研究
- 癌症治疗方法 癌症治疗方法
背景情况:
- 贝瓦西祖马布是一种关键的抗血管原性癌症药物,在印度有众多批准的生物类似药.
- 生物类药物市场日益增长,需要严格的可比性评估.
研究的目的:
- 对在印度销售的贝瓦西祖马布生物类似药进行全面的分析和功能生物相似性评估.
- 将创新产品 (Avastin) 与六种选定的生物类似药进行比较.
主要方法:
- 物理化学表征 (初级,高阶结构,杂质概况,翻译后的修改).
- 功能性特征 (SPR,细胞增殖试验).
- 生物相似性的基于化学测量的定量评估.
主要成果:
- 大多数bevacizumab生物类似药与创新产品具有显著的分析和功能相似性.
- 一种生物类似药物 (Biosimilar4) 在关键质量属性中显示出显著的偏差,包括单体含量,电荷变异和糖化.
结论:
- 虽然大多数印度bevacizumab生物仿制药与创新者非常相似,但仔细评估关键质量属性至关重要.
- 生物类4需要进一步调查,因为尽管符合产品规格,但观察到的偏差需要进一步调查.
相关概念视频
Bioequivalence: Overview
1.1K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.1K
Structure-Activity Relationships and Drug Design
757
Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
757
Biopharmaceutics and Pharmacokinetics: Overview
2.1K
Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
2.1K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
145
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
145


