What do Amjevita and the coming wave of Humira biosimilars portend for the future of immunology and the commercial prospects of future biosimilars across indications? There’s been steady speculation about how these biosimilars (more than 10 will launch by year’s end) might fare in the marketplace, but little to no hard facts.
Earlier this year, we looked at how likely these drugs are to benefit patients. Since then, we’ve surveyed payers, specialty pharmacists, patients and healthcare providers to understand how they’re thinking about Humira biosimilars. The decisions they make will affect patients downstream and have far-reaching consequences for biopharma manufacturers—whether they’re facing biosimilar competition or thinking about entering the field themselves.
The decisions insurers make about where a biosimilar appears on their formularies vis-a-vis Humira affect how likely doctors are to prescribe a biosimilar.
The takeaway: Big payers are too dependent on Humira rebates to risk disadvantaging the drug in the near term. As a result, early adopters are much more likely to be small and vertically integrated. At least some payers will force patients to try multiple biosimilars before approving a branded agent, increasing the time it will take some patients to get on their drug of choice.
The takeaway: The relevance of interchangeability and patient support programs on HCP decision-making about biosimilars has declined significantly.
Specialty pharmacists’ top consideration for stocking biosimilars
- Total cost to acquire and stock biosimilar
- Payer influence and partnerships
- Formula concentration (high versus low)
- Supply reliability
The takeaway: Patient uptake of biosimilars will depend on doctors’ decision-making and out-of-pocket costs.
The attitudes and behaviors revealed here will have wide-ranging implications for pharma companies, depending on their individual portfolio strategies and exposure to biosimilar competition.
For biologic manufacturers
The presence of biosimilars in a market depresses the value of that market for all products.
- To command a premium for upcoming pipeline assets, manufacturers must clinically differentiate through head-to-head trials, identifying unique patient subgroups and other precision medicine approaches—or through a combination of all three.
- Ongoing real-world evidence studies for in-line portfolios must also prioritize head-to-head data, even if it’s just for patient subgroups.
For biosimilar manufacturers
While interchangeability for biosimilars may have some influence, drugmakers must make sure their products stand out in nonclinical ways that benefit patients.
- Interchangeability confers a negligible advantage in the eyes of doctors and payers.
- More salient features include ease of reimbursement, low patient out-of-pocket costs, patient-support programs and other value-added services.
We wrote last year about the EU’s new guidance on biosimilar interchangeability, which clarifies that approved biosimilars are fully interchangeable with both their reference product and any other biosimilar sharing the same. At the time, we predicted that the U.S. Food & Drug Administration would follow suit by eliminating its mandate for switching studies to demonstrate interchangeability. This reality is one step closer with the reintroduction, in July, of the Biosimilar Red Tape Elimination Act. The bill would also expedite the FDA’s approval process for biosimilars.
The EU’s stance on interchangeability derives from its experience approving roughly 70 biosimilars and monitoring them for more than 15 years. Even with such extensive experience with biosimilars, regulators still felt compelled to remove any lingering uncertainty as to the safety and efficacy of biosimilars in clinical practice. If the U.S. continues down this path, we anticipate further erosion of bias against biosimilars, increased competition and, in time, significant benefit accruing to patients.
If this legislation is passed, payers and providers will need to step up emphasis on product quality, reliability and supply assurance. At ZS, we continue to be energized by the evolution of patient-focused policy action and will continue to monitor this space to see how these sentiments progress.