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TRASTUZUMAB CANNOT BE SOLD AS A BIO
SIMILAR OF ROCHE’S TRASTUZUMAB
Justice Manmohan Singh of the Delhi High Court along with its recommendations. After the TC has
restrained Biocon and Mylan from selling, endorsed the recommendations made by NDAC, it
manufacturing, marketing and advertising refers the application to the Apex Committee, and
their Trastuzumab as a biosimilar of Roche’s only after both TC and the Apex Committee have
Trastuzumab which is sold under the brand names endorsed the recommendations of the NDAC,
of HERCEPTIN®, HERCLON™ and BICELTIS®. should the DCGI consider granting its approval to
such an application.
Trastuzumab enjoys a global reputation for being
an accepted biological treatment for HER 2 positive This usually time consuming process of consideration
breast cancer worldwide. Roche Products imports
and markets this innovator molecule in India. by the NDAC, the TC and the Apex Committee
Biocon Limited along with Mylan Inc. co-developed
a purported biosimilar version of Trastuzumab, was done in a
and obtained an approval to market and sell the
purported biosimilar version of Trastuzumab. short span of five The undue haste with which the
Roche moved to the Court against Biocon, Mylan
Inc., and Mylan Pharmaceuticals Private Ltd. The days i.e., between approval was granted suggests that all
Drug Controller General of India (DGCI) who
granted the approval to Biocon and Mylan was also 18th October to factors relevant to the approval of a
made a party to the suit.
23rd October biosimilar drug under the Guidelines
Roche contended that Biocon and Mylan’s product
is, inter alia, being misrepresented as “Trastuzumab”, 2013. The undue on Similar Biologics and under other
“biosimilar Trastuzumab” and a biosimilar version haste with which internationally recognised standards
of HERCEPTIN® without following due process the approval was were not taken into consideration at
for obtaining appropriate approvals in accordance granted suggests the time of granting such an approval.
with the Guidelines on Similar Biologics. Roche also that all factors
argued that Biocon has not conducted various tests
required under the law for drug approval including relevant to the
Phase I and Phase II trials and has not independently
generated requisite data in order to demonstrate approval of a biosimilar drug under the Guidelines
similarity between their drug and the Plaintiffs’
Trastuzumab, both in terms of the stages and the on Similar Biologics and under other internationally
sample size of the tests conducted.
recognised standards were not taken into
It was also averred that as per the procedure
for the approval of new drugs in India, after the consideration at the time of granting such an
New Drugs Advisory Committee (NDAC) has
reviewed an application for a new drug and given approval.
its recommendation, it refers such an application
to a Technical Committee (TC), for consideration The Defendants argued that the application for
manufacture of its drug was in conformance
with the statutory requirements as contained in
the relevant Rules read with schedule Y of the
Drugs & Cosmetics Act. Under the said Act and
corresponding Rules, the term “Similar Biologics”
has not been defined. The “Guidelines on Similar
Biologics: Regulatory Requirement for Marketing
Authorization in India” are not statutory under
the Drugs and Cosmetics Act and the Rules
made thereunder and are only for the purpose of
providing guidance to the pharmaceutical industry.
It was averred by the Defendants that at the time
Biocon made an application for the biosimilar, phase
44 | Patents & Design
