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Revision of biosimilar guidelines by CDSCO in line with global norms to boost biosimilars access; Experts
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Shardul Nautiyal, Mumbai
December 22 , 2016
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With Indian market benefiting from quick product regulatory approvals in
biosimilars, the recent revision in guidelines by Central Drugs
Standard Control Organisation (CDSCO) has made it more aligned with
global regulations.
Besides this, regulatory landscape for
biosimilars has been evolving with the global pioneer European Medicines
Agency (EMA) also setting the trend, say experts.
Biosimilars
are copy versions of already approved originator biologics that are
marketed after patent expiry for the originator product. As the safety
and efficacy of the innovator product is already established, copy
versions are allowed to be developed and evaluated using an abbreviated
pathway established on biosimilarity principles.
Since the first
set of over-arching guidelines for biosimilars were released by the
European Medicines Agency (EMA) in 2005, there has been much development
in this space. The US Food and Drug Administration released its first
set of draft guidelines in 2012, which have since been finalised.
Additional guidelines were released in 2014-15. China FDA released its
biosimilars guidelines last year.
Says Dr Charu Manaktala, senior
medical director, Biosimilars Centre of Excellence, Strategic Drug
Development, QuintilesIMS Asia, “The basic regulatory framework for
biosimilars registration has been established fairly well by 2016. The
year also marked the 10th anniversary for approval of the 1st biosimilar
in the EU. A number of regulatory guidelines are in place as well as a
good amount of experience has been gained on a number of biosimilars
ranging from simple proteins to complex monoclonal antibodies. Some of
the other highly regulated markets such as Japan, South Korea, Canada,
Australia among others have adopted EU biosimilar guidelines to a large
degree.”
In addition to the revision of some of the earlier
guidelines, the EMA published guidelines for pharmacovigilance of
biologics in 2016. The US FDA has published a guidance on the labelling
of biosimilars in March 2016.
The naming of biologicals and
interchangability of biosimilars continue to be hotly debated topics.
The EMA has approved biosimilars under the same non-proprietary name as
for the reference product. In 2015, the US FDA issued draft guidance on
the subject of non-proprietary naming of biosimilars. This guidance
recommends that all biologicals should have non-proprietary names that
includes a four-letter suffix to distinguish them from each other. The
suffix would be composed of four lowercase letters and not carry any
meaning.
The proposed approach is intended with a view to
clearly identifying biological products to improve pharmacovigilance,
and, preventing any unintended substitution. However, a number of
industry stakeholders, including the USP have requested for alternative
approaches to be considered.
While the interchangability
guidance from the US FDA is awaited, Sandoz recently reported study
findings that show lack of safety and efficacy impact from multiple back
and forth switches between the it’s etanercept biosimilar and the
originator product.
“We expect to see more products obtaining
marketing approval on the basis of lean clinical data packages
especially where validated PD markers are available, supported by strong
quality comparability, in vitro biological activity evidence and
clinical PK-PD studies,” adds Dr Charu Manaktala.
Asian
manufacturers, especially from South Korea, continue to be key players
in the current biosimilars landscape, with rich product pipelines as
well as a number of approved products in both the EU and US.
South
Korea is reported to have a goal of controlling 22% of the global
biosimilars market by 2020. This goal is supported by the Korean
government by way of providing capital as well as regulatory assistance
to the domestic biopharmaceutical companies.
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