Malhotra Hemant
Division of Medical Oncology, SMS Medical College Hospital, C-70 Ram Marg Tilak Nagar, Jaipur, India.
Biologicals. 2011 Sep;39(5):321-4. doi: 10.1016/j.biologicals.2011.06.018. Epub 2011 Jul 23.
Globally, a large number of blockbuster biotherapeutic molecules are going off patent in the next few years. For emerging economies, like India, it is imperative to be able to provide safe and cost effective drugs for its huge, non-insured and poor population. India has a robust pharmaceutical industry including the biopharmaceutical sector which is actively engaged in the production and marketing of 'non-innovator' or 'copy' biotherapeutic products These products are approved through an abbreviated route which relies on limited safety and efficacy data enabling the local companies to keep the production costs low and pass on the price benefit to the patient and make the product affordable to the masses. Some of the available products may not be truly 'similar' and may be of suspect quality. The WHO [1] and the European Medicines Agency (EMA) [2] have published guidelines for the development and marketing of biosimilar products. These products, as stated in both guidelines undergo extensive head-to-head comparability testing with the reference biotherapeutic product (RBP) to show their similarity to the RBP in terms of quality, efficacy and safety. Regulators and administrators of different countries need to strike a balance in cost-to-benefit versus risks that are perceived for these products, keeping in mind global regulatory issues.
在全球范围内，大量重磅生物治疗分子将在未来几年内专利到期。对于像印度这样的新兴经济体来说，为其庞大的未参保贫困人口提供安全且具成本效益的药物势在必行。印度拥有强大的制药行业，包括生物制药领域，该领域积极从事“非创新型”或“仿制”生物治疗产品的生产和销售。这些产品通过简化途径获批，该途径依赖有限的安全性和有效性数据，使本土企业能够保持低成本生产，并将价格优势传递给患者，让大众能够负担得起这些产品。一些现有产品可能并非真正“相似”，质量也可能存疑。世界卫生组织（WHO）[1]和欧洲药品管理局（EMA）[2]已发布了生物类似药产品研发和上市的指南。正如这两份指南中所述，这些产品要与参比生物治疗产品（RBP）进行广泛的直接对比测试，以证明其在质量、疗效和安全性方面与RBP相似。不同国家的监管机构和管理人员需要在这些产品的成本效益与感知风险之间取得平衡，同时牢记全球监管问题。
