The biosimilar landscape

The general landscape

• The rate of drug discovery and innovation, particularly for biologics, continues to put extraordinary pressure on healthcare budgets. We believe biosimilars are central in addressing this, enabling innovation as well as increased patient access to life-changing medicines.
• The availability and adoption of biosimilars has grown exponentially over recent years. Not only are more companies now developing biosimilars, including those in emerging markets, but competition within therapy areas is becoming increasingly fierce, fueling the need to differentiate biosimilars beyond price to help protect market share.
• In the future, we can expect to see biosimilars expand into new therapy areas, including multiple sclerosis and rare diseases. Improving awareness and education about biosimilars among these clinical communities will be key to ensuring optimal uptake and increasing patient access to essential treatments.

The European landscape

• In Europe, we have already seen how biosimilars have transformed patient lives. In Germany for example, prior to the launch of the first biosimilar approved for rheumatoid arthritis, patients had to wait over 7 years to be treated with a biologic. This is now just 2–3 months following the introduction of biosimilars in this therapy area.
• Whilst Europe has led the way in terms of biosimilar approvals, with 73 biosimilars approved for use as of August 2022, there is significant variation in their level of adoption across countries and therapy areas. This is due to a multitude of reasons, including inequalities in access to biologics and differing reimbursement models and national policies. The need for education to provide reassurance and increase confidence in biosimilars remains an important priority to address these variations.

The US landscape

• From a regulatory perspective, whilst the US did not approve its first biosimilar until 2015, almost a decade after Europe (2006), data suggests the US biosimilar landscape is now advancing faster than Europe's. The FDA has approved 36 biosimilars in the 8 years since the first was launched in the US, compared to 15 biosimilars in Europe in a comparable time frame.
• The uptake of biosimilars in the US was initially slower than in Europe due to complexities around the reimbursement landscape and opaque patent protection of originator drugs, but momentum has picked up in the last couple of years. This has particularly been driven by their use in oncology, where biosimilars for rituximab, bevacizumab, and trastuzumab have all exceeded 60% market share since their first biosimilar launch in 2019.
• Insurance companies in the US have begun to realize the savings from biosimilars, which increased to approximately $8 billion in 2020 alone. Moreover, the upcoming availability of several adalimumab biosimilars in 2023 will represent the largest biosimilar cost-saving opportunity yet for US payers, HCPs, and patients.
• The expansion of biosimilars into pharmacy benefit reimbursement and the expected approval of interchangeability status for some biosimilars will further increase uptake and highlights the importance of educating pharmacists on how to discuss biosimilars with patients.