CDSCO may further revise Biosimilars Guidelines

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With Indian market benefiting from quick product regulatory approvals in bio-similars, 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.

However some experts like Dr Charu Manaktala, senior medical director, Biosimilars Centre of Excellence, Strategic Drug Development, QuintilesIMS Asia pinpoint, “The general principles of what the regulators expect, such as step-by-step development, focus on robust comparability and functional interests, pharmacovigilance – all of these are aligned with other guidelines.

She says that some points in the recent provision are contentious like the number of subjects required for different phases of development, but we need to have a more pragmatic view.

Compared to the pre-2012 era, she adds, “We have made significant progress. There is scope for revisions to further align our guidelines with the world view, but we are in a relatively good position.

“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,” Dr Manaktala concludes.

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 bioplharmaceutical companies.

Source: 1, 2

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