The bulk of the discussion at this year’s ACCESS 2025 conference fell into four buckets: (1) the effect of the Trump administration’s tariffs on the active pharmaceutical ingredient (API) supply chain, (2) the magnitude of the potential lost opportunity for biosimilars that are not developed (or the “biosimilar void”), (3) the effect of the Department of Government Efficiency (DOGE)’s early retirement initiative, and (4) the effect of the new private-label channel in the biosimilar marketplace. In the initial installment of a two-part report, we cover the first two topics.
The disruption of the chaotic first couple of weeks of the new administration had conference attendees worried about future revenues and the ability to commercialize their products. The speakers at this Association for Accessible Medicine’s (AAM’s) conference gave them plenty to consider, some from former members of the President’s first administration among others.
Both the keynote speaker and opening address emphasized the danger to the pharmaceutical markets as a result of the Trump administration’s tariffs on the API supply chain. “The Chinese market is a key supplier for key starting materials and APIs for the generic supply chain,” said John Murphy III, AAM President and CEO.
Keynote speaker Marc Siegel, MD, Physician, NYU Langone Medical Center and a medical commentator for Fox News, emphasized the tariffs on China are meant to address the exportation of fentanyl, it is a blunt tool that cannot “target the chemicals in fentanyl without having massive reverberations across medications, many of which are in short supply.”
He reminded the audience that “very few medications are actually made in the US. Over half of generics are made overseas (mainly China and India).” Overall, the tariffs will worsen current drug shortages in this county.
Dr. Siegel continued, “It will take years to build up infrastructure in the US to do more API manufacturing here. API production in the US has dropped 61% in the last decade, because it’s cheaper to do it elsewhere. This is a path in the wrong direction.”
THE BIOSIMILAR VOID AND MISSED OPPORTUNITIES
Just prior to the conference, IQVIA released its report on the biosimilar void (the report was sponsored by AAM). Murray Aitken, MBA, Executive Director, IQVIA Institute for Human Data Science, explained that the term refers to the gap between the number of biologics losing exclusivity over the next 10 years, which dwarves the “very limited development of biosimilars candidates” for those reference products.
This encompasses “118 molecules, accounting for $230 billion in revenues, but there are biosimilars in development for only 12 of these molecules (based on public disclosures). We think this report is a wake-up call for all stakeholders,” said Dr. Aitken. “It needs to be visible and discussed.”
Interviewed by Craig Burton, Senior Vice President of AAM and Executive Director of the BIosimilar Council, Mr. Aikten cited contributing factors, including the limited sales of several agents, some of which are used solely for rare diseases, and others are very complex molecules (which are difficult to manufacture). Dr. Aitken pointed out that the CAR-T treatments also are part of this group, and they are associated with yet with another level of complexity.
Mr. Aikten pointed out that 2024 was the 40th anniversary of the Hatch–Waxman Act, which officially ushered in the age of generics. “Are we on track for biosimilars to play a similar, central and essential role in the healthcare ecosystem?” he asked. “We still have regulatory requirements that cause issues (e.g., interchangeability, healthcare professional and patient reticence about biosimilars), and the ASP pricing mechanism was not designed for biosimilar reimbursement. The ASP pricing mechanisms are driving down prices on some products to unsustainable levels.”
“On the dispensing side, challenges remain for biosimilars to play a role on the formulary as the low-cost option. The pricing mechanism for pharmacy benefit products does not fit the purpose for a well-functioning market,” he explained. Pricing dynamics have not played out to realize sufficient revenue to manufacturers,” and this will hinder future biosimilar development plans.
As a result, we may be looking into a black hole of future missed opportunity. The current policies and incentives for biosimilar development do not seem up to the task of enabling lower-cost competition for this vast array of biologics.
In our next post, we’ll report on the staffing effects of DOGE, as well as the effect of private labeling on the biosimilar marketplace.
