Biosimilars Snapshot

In key markets, companies face multiple challenges bringing a biosimilar to market – but there is huge potential.

March 2021

Dr. Aviral Maheshwari, Vice President; Dr. Anuj Gupta, Director; Nishika Bhan, Associate Director

Stakeholder centric solutions are key for biosimilars to win in the US market

The global biosimilars market is expected to grow exponentially this decade as more than 80 biologics, including Keytruda and Humira, are due to lose exclusivity during 2020-2029. However, it is yet to realize its full potential, with biosimilar developers recording limited penetration within key markets such as the US. In these markets, companies face multiple challenges, such as price slides by originators, evolving regulatory frameworks and negative perceptions of physicians and payers, off setting the cost advantage of biosimilars.

Over $48 billion of current biologics sales is expected to be challenged by biosimilars between 2019 and 2023.

More than 80 biologics across the US and EU are expected to face loss of exclusivity (LOE) from 2020 and 2029, with most having peak sales between $100 million and $1 billion.

The largest opportunities for biosimilars are expected in 2022-2023 (driven by the US sales of Humira) and 2028-2029 (driven by the US sales of Keytruda).

Over the next 5-10 years, multiple biologics will be exposed to biosimilar threats globally…

…however, there are several geographic variations, with the EU being the most evolved market for biosimilars.

The US is a key market for biosimilars; however, a slide in net price prohibits patient switches from reference biologics.

In 2017-2018, Remicade prices were gradually discounted by 3-7% per quarter to ward off competition from biosimilars.

Nearly 30 months after launch, infliximab’s biosimilar share in the US was only 8% in March 2019, compared to 80% in the UK and 45% in Germany.

Biosimilar developers need to significantly invest to show the similarity and interchangeability of biosimilars to maximize their potential, especially in the US.

Conclusion

Biosimilar developers need to build strategic and customized solutions to address the apprehensions of each stakeholder (payer, provider and patient) and facilitate early adoption of biosimilars. Given its years of experience and expertise in helping biosimilar manufacturers, Prescient can help clients design specific solutions focused on the unmet needs of each stakeholder in the targeted therapeutic area, leveraging the key strengths of their asset and company.