The Central Drugs Standard Control Organization
("CDSCO") has released draft guidelines
in an effort to streamline the regulatory process for granting
marketing permission to similar vaccines and other biosimilars in
India. The proposed revised Guidelines on Similar Biologics, 2016
("Draft Guidelines") seek to supplement
the earlier "Guidelines on Similar Biologics: Regulatory
Requirements for Marketing Authorization in India"
A. Biologics and Biosimilars
Biologics are medicinal products composed or derived from living
entities such as tissues and cells. They primarily include a wide
range of products such as vaccines, blood and blood components,
gene therapy, tissues and recombinant therapeutic proteins.
A biologic similar to another biologic is called a biosimilar.
In common parlance, it can be understood as the generic version of
a medicine, which can obtain registration upon proving to be as
effective as the original/innovation medicine.
B. Draft Guidelines vs. 2012 Guidelines
The Draft Guidelines attempt to simplify the process for
marketing approval in India for a biologic (say a vaccine) which is
similar/comparable to another biologic/vaccine already approved for
marketing in India, or elsewhere in the world, as specified.
Biosimilars (as well as other generic versions of medicines) are
usually attempted to be manufactured and marketed after expiry of
the patent of the original drug or in case of healthcare
Although the 2012 Guidelines were mostly aligned with global
requirements, the Draft Guidelines seek to introduce ICH
referencing and stipulate that a reference biologic (based on which
the biosimilar seeks approval and entry into India) if not
marketed/licensed in India, should be licensed in a country that
has adopted the Technical Requirements for Pharmaceuticals for
Human Use prescribed by the International Council for Harmonisation
The ICH referencing in the Draft Guidelines may attract
criticism. Reportedly, the CDSCO has itself in the past blocked
import of ICH standards in Indian regulations. The CDSCO and
various other groups have opposed ICH, arguing that ICH is a pharma
industry driven body, prescribing such high standards which do not
necessarily add value beyond a certain point but definitely add to
the cost of manufacturing of medicines. India has a thriving
generic drugs industry, and generic drugs are arguably required to
provide healthcare to the vast Indian population at an affordable
price. Reportedly, the ICH also does not find much approval even
with organizations advocating for low/middle income countries.
The 2012 Guidelines did not prescribe ICH referencing and
stipulated that a reference biologic could come from any country
with a well-established regulatory framework. The ICH referencing
prescribed in the Draft Guidelines may arguably impose an indirect
barrier for approvals of biosimilars in India.
In addition to the above revision, the Draft Guidelines
prescribe that Phase III trials for biosimilars shall have at least
100 evaluable patients and Phase IV trials shall have at least 200
patients. The Draft Guidelines also permit a smaller trial
population size for trials of biosimilars for treating rare or
severe diseases or where therapeutic options are limited. The 2012
Guidelines did not specify the minimum number of patients. It is
generally expected that specifying a minimum number of patients
will ensure maintenance of uniform safety data.
The Draft Guidelines are open for suggestions and feedback till
April 30, 2016.
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