Biosimilars appear ready for prime time in the U.S. as reimbursement is increasingly value-based

Biosimilars are launching soon in several categories, including auto-immune disorders and ophthalmology

2023 will likely be a pivotal year for biosimilars, as Humira-referenced adalimumab products launch in the U.S. Worldwide, Humira has been a massive blockbuster for AbbVie, but also a drain on payer budgets. Once Humira-referenced biosimilars were marketed in Europe, they took off in many countries, as payers sought to reduce financial exposure with heavily discounted products. Steep discounts and tender offers, in which the best bid gets the lion’s share of the market, have helped boost uptake of biosimilars. Additionally, European payers have bought into the value proposition that biosimilars are cost-effective.

Besides auto-immune disorders, biosimilars are entering new therapeutic areas such as ophthalmology. Together with Samsung Bioepis, Biogen is launching Byooviz (ranibizumab) this month. Byooviz is a biosimilar referencing Lucentis. Approved by the FDA in September of last year, the drug will soon become the first ophthalmology biosimilar in the U.S. Byooviz’s approved indications include wet age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Byooviz is being offered at a list price of $1,130 per single-use vial, which is a 40% discount off the wholesale acquisition cost of Roche’s originator, Lucentis. It’s expected that the price of Lucentis will also drop.

But, selling biosimilars like Byooviz to payers and clinics isn’t as simple as discounting the price. As with any new biosimilar, detailing Byooviz’s launch – demonstrating its value - will be an elaborate endeavor, which involves engaging doctors, payers, and patient advocacy groups to facilitate access and appropriate physician and patient support. Biogen, for instance, has said it will be educating ophthalmologists about the science and value of biosimilars, as well as the regulatory framework for its approval.

In the U.S., policymakers firmly believe that safe, effective, and lower-cost biosimilars must be made available to all who need them. However, biosimilars have sometimes been excluded from formularies owing to rebate schemes. In this context, higher-priced originator medications are sometimes preferred by some U.S. payers as rebates are larger for those products. Indeed, perverse financial incentives in the U.S. have been a limiting factor with respect to increasing adoption of biosimilars.

Nevertheless, with employers and patients demanding more pass-through of rebates and the role of cost-effectiveness and value-based pricing gradually becoming more important to payers, it’s expected that biosimilars will ascend in market share across all therapeutic categories where they are available.

Indeed, after a painfully slow start from 2015 to 2019, the U.S. has finally been experiencing a sustained uptick in the uptake of biosimilars in the past few years. Robust biosimilar penetration is now apparent across several therapeutic classes. In addition to the filgrastims and pegfilgrastims, there’s been erosion of the originator biologic market share in the trastuzumab, rituximab, and bevacizumab classes.

Biosimilar usage can be bolstered by value-based contracts in which financial incentives of key stakeholders – payers, drug manufacturers, and healthcare providers - are aligned. For example, payers can institute capitated contracts with healthcare providers which hold those who prescribe originator biologics and biosimilars accountable in part for the total cost of care. Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of value-based purchasing agreements. The Lyfegen platform identifies and operationalizes value-based payment models in a cost-effective manner.

Undoubtedly, payers who are less reliant on rebate arrangements and therefore more cost- and value-conscious will be able to achieve a decrease in overall costs, as lower-priced biosimilars introduce market competition within therapeutic classes. In turn, this sparks steeper discounts across all drugs, including originator products.

What may further ameliorate the adoption of biosimilars Is the granting of therapeutic interchangeability designation to certain products. To illustrate, on July 28th, 2021, the FDA approved the first interchangeable biosimilar product, Semglee (long-acting insulin glargine), which implies that it can be automatically substituted at the pharmacy counter. This has ushered in more competition, specifically in the insulin glargine class. Furthermore, one of the six biosimilars referencing Humira (adalimumab), Cyltezo, is now approved as therapeutically interchangeable and may be automatically substituted for its reference product Humira. All six approved biosimilars, including Cyltezo, are slated to enter the U.S. market at different points in 2023.

When determining the cost-effectiveness and budgetary impact of biosimilars, payers must consider dynamics, such as the distinguishing between the initiation of treatment-naïve patients on a biosimilar and therapeutic switching practices, as well as price competition with alternative therapies, and the effect of originator companies who can introduce biobetters, or improvements – often in terms of formulation and dosing – on their original product. Lyfegen can assist with evaluation of the cost-effectiveness of biosimilars and biobetters.

Armed with information about biosimilar and originator biologic clinical efficacy, patient preference, and treatment costs - which Lyfegen can provide - payers will be positioned to make appropriate coverage decisions.

About the author

Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst and consultant on a variety of research, teaching, speaking, editing, and writing projects.

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