Bio-dynamism: Insights into the Biosimilars market

Considered a major hope for the effective treatment of several diseases that have no cure till date, development of biotech medicines has been embraced as a core research and development area across some of the largest and populous economies in the world.

With rising healthcare costs, the impending patent cliff and a relatively slow pace of development of generics, development of biologics is regarded as one of the most promising frontiers in pharmacotherapy, with biologics expected to have a global market to the tune of US$ 3.7 billion by 2015.

Benchmarking against the performance and regulation in the leading nations of the world indicates that the value generation opportunity of biosimilars is dependent on several factors, including speed of development, clarity in regulation, ease of access and particularly the roles of all stakeholders. Potential aside, there remain regulatory challenges, success of clinical trials as well as safety and efficacy tests which are characterized by a huge investment outlay.

- Mahadevan Narayanamoni, National Leader, Healthcare and Life-sciences Advisory, Grant Thornton India LLP

Broadly classified as a follow on or modified biologic, by definition, biosimilar can be a “copy of” or “similar to” the biological drug whose patent has expired, but not identical to the biological drug. Unlike chemical-based generic small molecule drugs, biosimilars are large complex drugs involving the use of living cells resulting in challenges around uniformity and consistency. In common parlance, biobetter, biosimilar and antibodies are quite often used interchangeably.

However, there is a vital distinction between these classes. With each class having different characteristics, it becomes imperative to understand the distinction between “highly similar” or “completely interchangeable” products, the defining factors being the following:
• whether it can be substituted without a doctor‟s prescription?
• does it produce the same clinical result with safety and efficacy?
• is it similar to the reference product?

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