New general guidelines issued by India’s biotechnology department and drug regulator on biosimilars will take effect August 15. The guidelines, which took five years to develop, are the country’s first for biosimilars. The guidelines state that to develop biosimilars, firms should consult an original product authorized in India or a product approved and sold in another country for at least four years that has safety and efficiency data. There have been biosimilars authorized in India without utilizing a suitable number of patients in a clinical trial. The guidelines summarize data requirements for preclinical and clinical trials but lack other details. India’s drug regulator said that as the industry accepts the guidelines, more details will be finalized. The guidelines’ development was accelerated after Sri Lanka rejected some Indian biosimilars because of the lack of set guidelines.

Source: Business Standard