Abstract

Biobetters are new biological entities, that are related to approved biologics by target or action, but they are intentionally altered to improve disposition, safety, efficacy, or manufacturing attributes. Due to the growing need for lower cost better versions of biological medicines, the markets for biobetters are rising. Regulatory authorities of many countries have precise technical standards and legal pathway for approval of synthetic drugs. The objective of the article is to view the different approaches taken by the ICH countries in regulating biobetters; strictly, there are no specific guidelines for biobetters but biosimilar guidelines are adopted. In March 2010, United States (US) passed the Biologics Price Competition and Innovation Act; but Europe had biologics approval process since 2005, while Japan since 2009. In US, it requires to provide clinical data of the drug for multiple years; same as provided by the innovator drug whereas in Europe it is not required to do so, but safety and efficacy data is required. The critical issue in biological with reference to small molecules (drugs), might be to influence doctors, other healthcare professionals and patients that biobetters have sufficient similarity to risk compared to existing biologics. A full preclinical package may be required unless to prove the differences between the biobetters and the innovator products are petite.

Keywords: Follow-on biologics, Biobetters, Pathway, Similarity, Preclinical, Safety and efficacy.

Graphical Abstract