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India’s biosimilar norms of August 2016 on par with global requirements: Dr Bobby George
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Nandita Vijay, Bengaluru
April 01 , 2017
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India’s latest biosimilar guidelines of August 2016 are considerably on
par with global requirements. There is now enhanced scope for product
registrations, said Dr. Bobby George, vice president & head,
regulatory affairs, Reliance Life Sciences.
The applicable
guidelines in India are Drugs and Cosmetics Act & Rules; r-DNA
safety guidelines, 1990; Guidelines for generating preclinical data for
r-DNA products & other biologicals, 1999; IBSC guidelines, 2011;
CDSCO guidance for industry, 2008; and CDSCO-DBT guidelines on similar
biologics, 2016.
There is now more clarity on data requirements
at different stages of development of similar biologic (SB). Safety
surveillance needs to be given more priority now. Companies who are
mid-way through their drug development processes need to adapt to the
new requirements quickly. The abbreviated data requirements are
applicable only for preclinical and clinical development program but not
for the quality data through demonstration of comparability to the
reference biologic (RB), he added.
While highlighting on the
opportunities, threats and differences from the 2012 guideline, he
focused on the regulatory requirements for market authorisation in
India. If the RB is not marketed in India, then it should be licensed in
any ICH country. This is in contrast to the 2012 guideline, which
mentioned that the RB should have been licensed and widely marketed for
four years post approval in the country where the innovator product was
approved with a well-established regulatory framework, said Dr. George
who was speaking at the Bio Pharma Asia Convention at Singapore
recently.
In manufacturing, ‘upstream process’ data should now be
described in detail including media components used for cell growth.
Further, details of upstream process kinetics data from consistency
batches need to be submitted. The 2012 guideline just mentions that
‘fermentation process’ data should be from a representative batch.
In
the case of ‘downstream process’, additional requirements have now been
included. The regulatory submission should incorporate detailed
description of the methods followed for cell harvesting and extraction
of the protein; description of post translational variation, if any;
virus clearance validation studies as well. Besides, one needs to
provide details on the removal of impurities like product related
variants, he said.
The process related impurities pose a risk of
immunogenicity he said. The critical quality attributes (CQAs) have
direct impact on the clinical safety or efficacy but must be controlled
within limits that need to be established based on the RB. The product
shelf life would now be assigned based on the extent of available real
time stability data only as per current guideline. The safety data
collectively from phase 3 and 4 trials should now be derived from a
minimum of 300 patients treated with SB pointed out Dr. George.
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