Page 22 - A&A Patents&Design Rewind-2016

REVISED GUIDELINES ON SIMILAR BIOLOGICS IN
INDIA
The Central Drugs Standards Control Or-
ganization issued the ‘Guidelines on Simi-
lar Biologics: Regulatory Requirements for
Market Authorization in India 2016’ to ‘provide re-
quired clarity and essentiality of data requirements
for proving similarity, physico-chemical characteri-
zation, pre-clinical studies and clinical trials’. These
Guidelines are a revision of the 2012 Department
of Biotechnology-Central Drugs Standard Control
Organization (DBT-CDSCO) Guidelines for the
development and approval of Similar Biologics. The
Guidelines define a Similar Biologic product as a
product which is similar in quality, safety and effica-
cy to an approved reference product.
The 2016 Guidelines, with a few exceptions, are
similar to the 2012 Guidelines. The salient features
of the Guidelines are as follows:
1. The Guidelines permit the use of a Reference
Biologic which is not approved in India,
provided it has been approved or licensed and
marketed in any of the International Council
for Harmonization of Technical Requirements
for Pharmaceuticals for Human Use (ICH)
countries. It is further, permissible to
import the reference biologic for conducting
comparative studies.
2. So far as the manufacturing process of the
Similar Biologic is concerned, it should yield
a product comparable in terms of identity,
purity and potency to the Reference Biologic.
Upstream processes should be described in
detail including the media components used
for cell growth and said processes should be
well controlled and monitored. A detailed
description of the downstream methods,
namely, methods followed for cell harvesting
and extraction of the protein should be
provided.
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3. The Applicant is further required to submit the
following details:
a. Post-translational variations, if any,
b. Details of removal of impurities like
product related variants & impurities,
and host cell and process related
impurities considered to pose a risk of
Immunogenicity (EMEA 1997).
c. Virus clearance validation studies.
4. Quality Attributes of a Similar Biologic have
been categorized into two: Critical Quality
Attributes (CQA) and Key Quality Attributes
(KQA). Critical Quality Attributes (CQA) are
those quality attributes which have a direct
impact on the clinical safety or efficacy while
Key Quality Attributes (KQA) are those quality
attributes which are not known to impact
clinical safety and efficacy but are considered
relevant from a product and process
consistency perspective. While CQAs need to
be controlled within limits established based
on the reference product, it may be acceptable
to have slight differences in comparison to the
reference product for the KQAs. In a clinical
trial application the quality data submitted
should indicate that there are no differences
in CQAs and the KQAs are well controlled to
allow clinical evaluation.
5. The revised Guidelines permit the filing of
parallel applications to Review Committee on
Genetic Manipulation (RCGM) and DCG(I)
seeking approval to conduct clinical trials.
However, the DCG(I) can complete scrutiny
of the application and issue a permission only
post receipt of the RCGM recommendation.
6. The study on Normal Healthy Volunteer
(NHV) can be performed parallel to the phase
III safety and efficacy study.