The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process.
The regulatory framework has been designed to reduce the reliance on “unnecessary clinical testing” during the approval process. This means that biosimilar manufacturers will no longer have to conduct comparative efficacy studies on their prospective drugs.
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Instead, the FDA will use its accrued experience in assessing applications through comparative analytical and clinical studies to help determine if a biosimilar’s efficacy and safety is akin to its branded counterpart.
Alongside its change in stance on comparative efficacy trials, the agency also no longer recommends switching studies, as they can “slow development” while creating “confusion amongst the public” regarding biosimilar safety. Switching studies have traditionally been conducted to prove a biosimilar is as safe and effective as the branded alternative.
Through this draft scheme, FDA Commissioner Marty Makary noted that the US could see “massive cost reductions for advanced treatments”, specifically in rare diseases, oncology and autoimmune diseases. He also noted that, under the framework, manufacturers could save approximately $100m in development costs, while cutting biosimilar development timelines in half.
Under a separate initiative, the agency will also simplify the process of developing interchangeable biosimilars, meaning that patients and prescribers can easily identify low-cost brand alternatives.
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By GlobalDataThis biosimilar push closely follows the debut of the FDA’s ANDA generic pilot prioritisation scheme, which was introduced in early October 2025. Pharmaceutical Technology previously spoke with Giuseppe Randazzo, senior vice-president of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), about the implications of this framework.
Tackling drug pricing concerns
The introduction of this draft guidance comes amid drug pricing concerns in the US – a phenomenon that especially applies to complex biologic medicines.
While branded therapies represent just 5% of US prescriptions in 2024, they accounted for a little more than half of the nation’s total drug spend that year. This highlights the high-cost burden of branded drugs on both the US healthcare system and the patient population.
To address this, the FDA has gone for a ‘carrot’ approach while the Trump administration is trying its luck with the ‘stick’ method – threatening branded pharmaceutical manufacturers with 100% import tariffs if they do not reduce their US drug prices.
This saw Pfizer become the first pharma company to strike a deal with Trump, agreeing to cut US prices of select medicines in its portfolio in exchange for a three-year tariff exemption. AstraZeneca closely followed suit, signing a deal with the Trump administration around two weeks later.
Both Novartis and Roche are now in conversations with Trump around a Most Favored Nation (MFN) pricing deal, meaning the compatriots could soon reach an agreement with the administration.
However, GlobalData analysts are sceptical about the true impact of MFN deals on drug prices, as many patients obtain prescriptions through an insurance plan, meaning that concessions available through direct-to-patient (DTP) platforms such as TrumpRx.gov may not offer significant savings.
Industry sentiments mixed
While this draft guidance could be a step forward for the biosimilar industry, Cyrus Fan, healthcare and life science research analyst at GlobalData, noted that its debut was only a “small positive”.
He said: “The introduction of this draft guidance could potentially result in more FDA-approved biosimilars in the near future – particularly in cases where comparative efficacy studies are not feasible.”
However, Fan caveated that branded biologics will “still have control of the market” through patents, which act as a bottleneck to market entry for biosimilars. This means that the guidance “will not improve patient access to biosimilars”, but will instead expedite the biosimilar approval process.
Despite this, he stated that the framework could incentivise biosimilar manufacturers to produce their therapies in the US, as it would “reduce development timelines and costs”.
Meanwhile, AAM’s Biosimilars Council executive director and policy senior vice-president Alex Keeton expressed his enthusiasm for the guidance.
In a 30 October statement, he said: “Branded drug companies use arbitrary interchangeability designation to delay or block access to lower-cost biosimilar medicines, meaning fewer choices for patients and billions of dollars in missed savings for the US healthcare system.”
Keeton also noted that the US is the only country in the world that employs the interchangeability designation, which he believes is “unnecessary”.
He commented: “Updated analytical, functional and pharmacokinetic methodologies can detect clinically meaningful differences.” In his eyes, these methods are more effective than clinical efficacy studies.
According to GlobalData’s Intelligence Centre, there are currently 836 biologics available on the US market. Of these therapies, under 10% are biosimilars, with 76 biosimilars receiving the FDA green light to date.
GlobalData is the parent company of Pharmaceutical Technology.
