The next decade of biologics facing loss of exclusivity will define the opportunities available to biosimilar manufacturers. The US and Europe will be key markets but these present their own challenges.
A slow start
Biosimilar executives the world over are furrowing their brows. It has been over a decade since the first biosimilar was approved in Europe and the mechanisms for a profitable future are still far from certain.
Companies are pleased with the recent rapid uptake figures, led by the Nordics, UK and Germany, but the simultaneous slide in net price concerns them. Dominant payers have pushed discounts of the winning biologics past the 80% mark over the list price of the reference product. Lower-than-expected returns are unwelcome in an industry where regulatory uncertainty and rising costs of biosimilar development are a concern.
Uptake in the US hasn’t helped either. As of March 2019, nearly 30 months after launch, infliximab’s biosimilar share in the US was only 8%. In contrast, the share at the same time in the UK was 80% and Germany 45%. Compounding this are later entries for rituximab, trastuzumab and adalimumab compared to the EU. As such, companies that had factored a strong uptake in the US have had to recalculate which markets will allow them to recover their costs.
This has many wondering what future opportunities exist for biosimilar manufacturers. Will they be attractive enough to warrant the upfront costs or will we see a different model emerge from smaller, eastern players?
IQVIA Ark Patent Intelligence was used to determine a list of biologic molecules with a loss of exclusivity (LOE) date within the next decade (2020-2029). Forecasted sales from IQVIA Forecast Link for the originators at the year prior to LOE can determine the potential opportunity for biosimilars (Exhibit 1).
The most dramatic point to note from Exhibit 1 is that the largest opportunity for biosimilars will be in 2022-23 and 2028-29 and these spikes are driven by US sales of Humira and Keytruda respectively. Throughout the next decade, the US shows higher sales potential than Europe, helped by blockbuster products. Europe’s opportunities sit around the $3-5bn mark in each two-year cohort for the next decade. The LOEs for Keytruda and Opdivo sit outside the cohorts for Europe and are therefore omitted.
In the near-term, the 2020-21 cohort for the US is driven by Novolog and in Europe by Soliris.