OBJECTIVES : The evolving biosimilar landscape, and potential generic introduction poses a threat to both originators and new entrants. The objective of this research was to assess the potential change in the ulcerative colitis landscape upon introduction of further biosimilars and generic tofacitinib (in 2027) in Europe and the US.

METHODS : In-depth interviews were conducted with leading clinicians and payer archetypes in the UK, France and the US. This was to define the impact of low-cost alternatives on prescribing, HTA outcomes (EU), formulary placement (US) and willingness to pay.

RESULTS : In the US, historically biosimilars have not had a significant impact, with originators fiercely contracting to lower net cost and to defend formulary position. This is not expected to change with the introduction of biosimilar adalimumab. However, generic tofacitinib may be implemented as a step-through for biologic-naïve patients who have had an inadequate response to conventional therapy (CT-IR), depending on the net cost, market share, and competitive response. In the UK, cost is expected to be the key driver for management. Currently, biosimilars (particularly adalimumab, since introduction in 2018) dominate CT-IR treatment due to mandated uptake from CCGs. Generic tofacitinib is expected to supersede CT-IR treatment with expected lower net cost and associated cost-offsets (reduction in hospital administration). Branded entrants will be subject to predatory pricing, and access may be challenging (restricting to later lines), but individual funding requests could be used to gain earlier access (via the BlueTeq system). In France, biosimilar and generic penetration is expected to be lower, with payer and clinician decisions being driven by comparative efficacy. Presenting a potentially greater willingness to pay for branded (if improved efficacy).

CONCLUSIONS : The UC treatment paradigm will likely evolve in the next 10 years to domination by biosimilars and generic tofacitinib, providing net costs are significantly lower than originators