当前位置: X-MOL 学术Indian J. Med. Res. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Similar biologics in India: A story of access or potential for compromise?
Indian Journal of Medical Research ( IF 4.2 ) Pub Date : 2020-05-01 , DOI: 10.4103/ijmr.ijmr_43_18
Ramesh Jois 1 , Sukumar Mukherjee 2 , S Rajeswari 3 , P D Rath 4 , Vishal Goyal 5 , Disha Gupta 5
Affiliation  

Biosimilars or similar biotherapeutic products are the biological products approved by regulatory agencies based on the demonstration of similarity in quality, safety and efficacy with reference biologics (or original biologics). Though biosimilars could be considered as interchangeable therapeutic alternatives over original biologics, there are concerns regarding their similarity in effectiveness and safety with reference product along with the level of evidence of similarity required for approval. The biosimilars, particularly, monoclonal antibodies that are developed based on the complex manufacturing processes, require stringent comparative evaluations. The Indian Regulatory Authorities in July 2012 developed the first guidelines for approval of similar biologics, which comprised requirements for the manufacturing process, quality evaluation, preclinical and clinical studies, as well as post-marketing studies. The 2016 guidelines, an update to previous guidelines, were released with the intent to provide a well-defined pathway at par with international regulations for the approval of similar biologics in India. This article highlights the key attributes of the 2016 Regulatory Guidelines and also describes the aspects such as interchangeability, nomenclature and labelling of similar biologics in India. Rigorous consideration is imperative for highly complex similar biologics of monoclonal antibodies on a case-to-case basis.

中文翻译:

印度的类似生物制剂:获取或妥协的可能性的故事?

生物类似药或类似的生物治疗产品是监管机构基于证明与参考生物制剂(或原研生物制剂)在质量、安全性和有效性方面的相似性而批准的生物制品。尽管生物仿制药可以被认为是原始生物制剂的可互换治疗替代品,但人们担心它们与参考产品在有效性和安全性方面的相似性以及批准所需的相似性证据水平。生物仿制药,特别是基于复杂生产工艺开发的单克隆抗体,需要严格的比较评估。印度监管机构于 2012 年 7 月制定了首个批准类似生物制剂的指南,其中包括生产工艺、质量评估、临床前和临床研究以及上市后研究的要求。2016 年指南是之前指南的更新,其发布的目的是为印度类似生物制剂的批准提供与国际法规一致的明确途径。本文重点介绍了 2016 年监管指南的关键属性,并描述了印度类似生物制品的互换性、命名法和标签等方面。对于高度复杂的类似单克隆抗体生物制剂,必须根据具体情况进行严格考虑。
更新日期:2020-05-01
down
wechat
bug