Julie Reed: The Status Quo for Biosimilars Needs to Change to Maintain the Industry

Amid anticipation that more adalimumab biosimilars will launch in the United States, market dynamics and changing pricing structures could make or break these products, argued Juliana (Julie) Reed, executive director of the Biosimilars Forum, during a presentation at the 2023 Asembia Specialty Pharmacy Summit.

In 2023, 8 to 10 biosimilars referencing Humira (adalimumab) are expected to enter the market after years of patent litigation cases that postponed launches. In January, Amjevita (Amgen) was the first adalimumab biosimilar to enter the US market.

Reed started her presentation by emphasizing the role biosimilars can play in addressing health equity, saying that women, seniors, and low-income patients will benefit the most from biosimilar competition. Education efforts that target these patient populations are needed to increase access and adoption of biosimilars.

She went on to explain that although market competition has been useful in lowering drug prices, competition only works where there is market access, which means having a lot of products on the market isn’t always enough. Payer coverage issues, rebate walls that incentivize prescribing the originator, and patent thickets that keep products from entering the market despite FDA approval continue to prevent biosimilar adoption and savings. Of the 40 FDA-approved biosimilars, only 27 have entered the market.

Additionally, although adoption has grown significantly in well-established areas of the US biosimilars industry, such as the oncology space, growth stagnated in 2021 and 2022. Reed warned that without biosimilar adoption and subsequent savings, companies may reconsider if biosimilars are worth the investment.

“What we're experiencing, why we as an industry are scratching our heads is we're not getting the cost savings or the market access and the uptake that we expected when we started down this journey….And if there's not a market to launch and to be successful in, it's a very high-cost proposition that companies are going to reconsider,” said Reed.

Reed noted how the pricing structure taken with Amjevita may influence pricing structures for all biosimilars to come. When Amgen launched the product, it used a dual pricing structure (5% and 55% lower than Humira) for the purposes of gaining access to formularies and rebates while still offering employers cost savings. Reed predicted more companies will take a similar approach and stressed that pharmacy benefit manager interference in formulary decisions are forcing this strategy.

Furthermore, the few payers that have publicized that they will cover adalimumab biosimilars have all said they will only cover a few and they will be on the same preference tier as the originator, limiting market competition and access for most adalimumab biosimilars.

Reed explained the ethical issue of step edits that require patients to “fail first” using the originator before being prescribed a biosimilar, saying that officials at the FDA that she’s spoken with agree with her.

“If a patient clinically failed on the reference product and the biosimilar is FDA approved to be the same safety, quality, and [efficacy], why would the physician ever give the same product to the patient?” Reed noted.

Reed summarized saying that things need to change at the industry and policy levels in a way that prioritizes patients over profits and backend rebates. She noted the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the Affordable Care Act and established the biosimilar regulatory framework.

“The status quo for biosimilars cannot continue if there is to be a biosimilars industry. What's really important about [the BPCIA] is the first authorization by Congress giving and authorizing the FDA to create competition through regulation of a competitive new competitive market. If this one fails, what one is ever going to [work]? And you're seeing wonderful new innovations but if you continue to have no competition, the cost for the access to any of these new innovations is going away."