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I and phase II clinical trials were not necessary as approximately 90 days by the DCGI
per the Drugs and Cosmetics Act and Rules. It was while in the present case marketing
further claimed that the DCGI had exempted phase authorization was granted within 8 days
I and phase II trials for Biocon on their application. from the submission of clinical trial
Further, since the main objective of phase I trial is to data by Biocon to the DCGI. A mere
establish comparative pharmacokinetics (pK) which recommendation was issued and no
data was generated in the initial part of the Phase III speaking order was passed.
trial a combined phase I and phase III trial had been – If the biosimilar drug applicant conducts
conducted. Biocon/Mylan tried to justify the lack of all clinical trials and complies with
Phase II data on the ground that POC studies are all protocols laid down by the Drugs
not required for follow-on products (biosimilars or and Cosmetics Act and Rules and the
generics). Guidelines on Similar Biologics, only
then the biosimilar applicant will be
Considering the overall facts and circumstances, entitled to use the same INN name as
Justice Manmohan Singh made the following prima- the reference product and that too only
facie observations:- for describing the drug and not as a brand
name. On a failure to comply with Drugs
– The approval by DCGI of Biocon and and Cosmetics Act and Rules and the
Mylan’s product is contrary to the Drugs Guidelines on Similar Biologics, the INN
& Cosmetics Rules, Guidelines on Similar name can be used only with a certain
Biologics as well as the directions issued level of distinction to avoid confusion
by the Supreme Court; and deception.
– The requirement laid by the WHO
– There is no valid reason on record for Guidelines on Evaluation of Similar
exemptions on phase I and phase II trials. Biotherapeutic Products, 2009 for
the package insert of the biosimilar
– Paragraph 7.3 of the Biosimilar guidelines product to be similar to the prescribing
requires the RCGM to recommend the information and package insert of the
required phases of clinical trials to be reference product does not mean that
conducted based on their assessment the biosimilar manufacturer can copy
of pre-clinical test results. In the instant the innovator’s package in a mechanical
case the RCGM recommended all four manner and make false claims. It also
phases of clinical trial. The DCGI does does not mean that the test data in
not have any expertise to analyse the relation to the biosimilar should not be
clinical reports and draw conclusions. included in the package insert.
– Merely stating that a part of phase I trials As the final finding in this respect is yet to be arrived,
has been conducted in combination the Court has given the following interim directions:
with phase III trials is contradictory to
the scheme of the Act as the trials have a) The Defendants may continue to manufacture,
to be registered with the regulatory market and advertise their product under the
authority under the provisions of the name CANMAb or Bmab-200 or Hertraz on the
Act and Rules. There is no evidence for basis of the approvals already granted without
registration of the separate trials in this calling their product as “bio similar” and/ or “bio
case. similar to HERCEPTIN, HERCLON, BICELTIS”
– The Mashelkar Committee Report,
relied upon extensively by the Defendant,
provides that the examination of clinical
trial data and response should take
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