Guidelines for the approval or licensing of biosimilars have evolved
over the past 18 years since the first introduction of biosimilars.
Amendments to these guidelines are constrained in the US by legislation
and in the EU and WHO due to collaborative consent requirements. The
MHRA has recently joined ICH and brought its guideline that is most
rational and scientific; it removes animal and clinical efficacy
testing, as evidenced by hundreds of studies, billions of doses
administered, and a better understanding of recombinant therapeutic
proteins. However, there remains a need to bring a neutral jurisdiction
guideline that all countries can adopt; while the EU, FDA, Japan, and
now the UK are the deciding countries, they all realize the shortcomings
and will be willing to support an ICH guideline, as proposed here.
Compliance with a unified ICH guideline will promote the entry of safer
biosimilars and cross-country registrations. This review is based on
identifying the shortcomings of the current regulatory guidelines and
scientific data to support the amendments proposed. These
recommendations have been submitted to the ICH and are under
consideration in the pre-Stage 1 consensus-building evaluation that will
require comments of scientists and regulatory authorities. A new ICH
guideline for the approval of biosimilars will bring global harmony and
enhanced accessibility of safer biosimilars.