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Trends Paving the Way for an Influx of Biosimilar Development

Promising broader patient access to critical medicines, biosimilars offer a more cost-effective alternative therapeutic option compared with originator products. With many patents for “blockbuster” commercial biologics set to expire in the next few years, biopharma developers have become increasingly drawn to the biosimilars market.

Understanding the benefits of having more readily available cutting-edge treatment options available for patients, a number of government and regulatory body-backed incentives are being introduced to streamline the biosimilar development process. In this article, Jim McNally, Chief Scientific Officer and Lynn Kamen, the company’s Scientific Officer, explore the incentives, regulations, and other trends pushing biopharma companies down the biosimilar development route.

A Drive Towards Biosimilars

At the onset of 2010, the biopharmaceutical industry witnessed an unprecedented wave of top-selling drugs reaching their patent expirations. Drug developers reacted quickly, recognising the potential for new biosimilar products when entering a market previously dominated by one player and acting to further establish the biosimilars market. With a total of 26 blockbuster molecule patents set to expire between 2022 and 2026, it can be expected that more developers in biotherapeutics will turn their hands to the biosimilars market.1

The potential to benefit financially from new exposure in the market is not the only driving force toward biosimilars. Lower development costs and more competitive product pricing quickly result in broader patient access to critical medicines. Innovator products that may have previously been too costly to distribute to patients in developing countries widely must make way for these often more affordable alternatives.

With the many advantages that can come from entering the biosimilars market as soon as possible after patent expiration, time is of the essence in what can be expected to be a competitive race to market. If timelines to critical milestones in biosimilar development cannot be accelerated, there is a risk that one of the many competitors will overtake, gaining the market share.