Optimizing Biosimilars Development

The Biosimilars market continues to grow with estimates suggesting that its value will reach $30 billion by 2025 and over $60 billion by the end of the decade. This remarkable growth is supported by several blockbusters loosing exclusivity between 2020 and 2025, biosimilars uptake increasing and regulatory environments evolving. Additionally, discount dynamics should stimulate demand and foster competition1.

In terms of Biosimilars uptake, main European markets are the ones with higher rates, although there are significant differences between countries and molecules. In United States, China or Japan a more developed regulatory landscape is allowing the market to expand. Thus, FDA has published several guidance documents aimed to provide more clarity on legal and regulatory matters and there is also a more favourable financing. China’s first four Biosimilars were approved in 2017 under a strict new framework created in 2015, but the inclusion of several biologic treatments in the National Reimbursement Drug List will likely give a further boost to the development of the Biosimilars market. In the case of Japan, biosimilars uptake has been supported by policy changes as the new guidelines published in April 2020 which, for example, provide incentives to medial institutes to prescribe self-injecting biosimilars 1.

In this scenario, Biosimilars mean an increasing opportunity for drug developers but, according to Mckinsey’s article “An inflection point for biosimilars”, one of the main strategic considerations for biosimilars focused companies should be to accelerate development and reduce its costs1, so it will be necessary to work with expert CRO partners capable of providing strategies to optimize time and investments.

Biosimilars regulatory landscape is complex, with differences between territories and constant changes and updates so, to successfully navigate this environment a flexible approach along with an active communication with regulatory agencies is essential.

Moreover, companies must adopt lean models of biosimilars development, with plans considering all aspects to meet operational and regulatory challenges and ensure effectiveness from the very beginning.

Linical has the experience, reach and capabilities to provide full support in Biosimilars development. With a flexible approach our team designs strategies to minimize risks and bring Biosimilars to the market in the most cost-effective way possible. With the right size, right reach and right team, Linical can help you navigate the most complex aspects related to biosimilars.

1. “An inflection point for biosimilars” by Ying Chen, Alex Monnard, and Jorge Santos da Silva. https://www.mckinsey.com/industries/life-sciences/our-insights/an-inflection-point-for-biosimilars