Regulatory Review of Abbreviated Biologics Regulations in ICH Countries
Venkatesh Madhugiri Prakash,
Chethan Kumar Reddy,
Pramod Kumar Teggin Math.
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.
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