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7. The Guidelines permit pharmacokinetics those products which are found to be similar
(PK) studies to be combined with phase III during pre-clinical, in-vitro characterization
clinical study in circumstances where the using established PK methods and those
pharmacodynamics(PD) marker is not available that have a PD marker surrogate of efficacy.
and the pharmacokinetic studies can be carried According to the Guidelines, the residual risk
out in patients. is significantly reduced in the phase I study if an
equivalence is demonstrated for both PK and
8. The Guidelines state that for Similar Biologics PD.
falling under the category of new drugs
according to the Drugs and Cosmetics 12. The Guidelines further provide that for safety
Act, 1945 phase III clinical trials for seeking and immunogenicity, if pre-approval studies
marketing approval shall be in accordance with were conducted on more than hundred
good clinical practices involving not less than patients, the number of patients in the phase IV
hundred evaluable patients in the test arm for study can be reduced such that the safety data
testing safety, efficacy and comparability. Phase (both from phase III and phase IV) is derived
IV trials may also be required in more than two from a minimum of 300 patients treated with
hundred patients. The primary aim of phase IV the Similar Biologic.
trials is generation of additional safety data
while secondary end points of the phase IV 13. Extrapolation of safety and efficacy data on
studies are efficacy and immunogenicity. The indications not mentioned by the innovator is
phase IV trials should preferably be completed not possible and said indications will need to be
within two years from the date of marketing covered in a separate application.
or manufacturing approval unless otherwise
justified. The phase IV protocol is to be 14. The Guidelines require the package insert
submitted with the marketing authorization of the Similar Biologic to be based on data
application. generated by the manufacturer or to be based
on verifiable publicly available data.
9. Where safety and efficacy studies are waived,
all indications approved for the reference 15. The Guidelines state that in the case of Similar
product may be granted for the biosimilar Biologics being evaluated for rare diseases, the
based on comparable quality, non-clinical data clinical trial population size can be reduced
and convincing PK/PD data. based on the rarity and severity of the disease
as well as the limitation to access to therapeutic
10. In situations where phase III study has been options.
waived, immunogenicity should have been
tested in the PK/PD study and will also be The Guidelines can be accessed at:-
analysed in the post-approval phase IV trial. https://patentsrewind.files.wordpress.com/2016/09/
guidelines-on-similar-biologics.pdf
11. Phase III clinical trials may be waived of for
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