Regulatory Approvals Open Floodgates for Biosimilar Competition

The US Food and Drug Administration's (FDA) approval of the first Infliximab biosimilar, Inflectra, in 2016 marked a pivotal moment for the biosimilars industry. With Infliximab being one of the highest grossing biologic drugs of all time, its patent expiration left the door open for biosimilar competition that could drastically lower treatment costs for patients with immune-mediated inflammatory diseases. In the years since, multiple other Infliximab biosimilars have gained FDA approval, ushering in a new era of lower-cost biologic options.

The approval of Inflectra from South Korean pharmaceutical company Celltrion was a milestone as it demonstrated the FDA's commitment to an abbreviated pathway bringing biosimilars to market. With proven similarity to the reference product established, Celltrion was not required to demonstrate clinical benefit again. This set the precedent for a streamlined approval process relying on analytical and clinical studies to prove biosimilarity rather than full clinical trial requirements. In the context of Infliximab's blockbuster sales history, its biosimilars presented a major cost-saving opportunity for both public and private payers.

Fierce Competition Drives Down Treatment Costs

The entry of multiple Remicade Biosimilars into the US marketplace has delivered on the promise of increased competition reducing drug costs. By 2020, four Infliximab biosimilars had gained FDA approval - Inflectra, Renflexis (also from Celltrion), Iixanza (from Boehringer Ingelheim), and Avsola (from Amgen). Faced with alternatives that are very similar but up to 40% cheaper, healthcare payers and providers rapidly adopted the lower-cost biosimilars. For example, one study found that two years after Inflectra's approval, over 20% of new Infliximab patients were receiving the biosimilar rather than the originator.

This shift had a direct impact on the bottom line. A 2021 analysis found that the availability of Infliximab biosimilars saved the US healthcare system over $1 billion from 2017-2019 alone. The lower average sales price also allowed more patients accessing treatment. As more competition enters a market, costs continue declining. For instance, AbbVie was forced to drop the list price of Infliximab by 30% in 2020 alone in response to biosimilar inroads. Early data confirms that this intense competition will potentially save $11 billion over the next five years.
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