Biosimilar market set to grow significantly, says report

Regulatory and commercial considerations are the primary drivers for successful biosimilar clinical development, according to a new report from Quintiles.

The report, An Integrated Approach to Biosimilar Development & Commercialisation, also states that successful biosimilar companies will be those who compress their clinical, commercial and regulatory thinking into a streamlined cohesive function as they proceed with developing biosimilars.

‘In the coming five years, we predict that entry hurdles for biosimilars will ease as new regional entrants and established global players begin to enter the market,’ said lead author Deepa Dahal, principal consultant, Consulting at Quintiles.

She added that the biosimilar market would grow significantly, creating an enormous opportunity for biopharmaceutical companies.

Yet, she warned, biosimilar development is a ‘uniquely difficult endeavour’ and successful development and commercialisation require a business strategy that ‘integrates a regulatory strategic roadmap, commercial and market access considerations, and appropriate clinical strategy and trial design’ and this strategy must be put into place in the very early stages of any biosimilar development programme.

According to the report, companies seeking entry into – or a sustained position within – the biosimilars marketplace, must:

• Identify the requisite regulatory stipulations for every market they intend to enter
• Address the various challenges in clinical development by identifying strategies to accelerate patient recruitment, selecting the right patient population and size to demonstrate similarity to the reference product – as well as to secure extrapolation to additional indications – and incorporating the right clinical endpoints
• Consider the commercialisation strategy early in the development process to account for the variance in uptake of biosimilars, including establishing a concurrent workstream to assess willingness to prescribe and pay for the potential biosimilar.

‘As the US FDA prepares to issue guidance on biosimilars, we are excited by the potential of biosimilar products to improve public health, especially to the extent that they can improve access among patient populations that have not had access to the innovator biologic due to high costs,’ added Dahal.

Amar Kureishi, Quintiles’ vice president and chief medical officer, who gave a presentation on the clinical development of biosimilars at BIO Korea in Seoul last month, said: ‘In the coming five years, we predict that entry hurdles for biosimilars will ease as new regional and established global players begin to enter the market.

The key question will then be how multiple biosimilars position themselves in the market, how they differentiate themselves from one another, and how prices will be affected.’