The onset of the new year brings with it the first major event in 2025: The launch of the first ustekinumab biosimilar (reference product, Stelara). However, several important developments will be worth watching over the next 12 months. Here are some of the most notable, including several ustekinumab biosimilar launches:
Ustekinumab: The Second Pharmacy Benefit–Covered Biosimilar
Six ustekinumab biosimilars have already been approved and have marketing dates, starting with Amgen’s Wezlana, an interchangeable version, which was allowed to launch on January 1.
The main indication (and greatest utilization for Stelara) has been for the treatment of inflammatory bowel disease, and this requires availability of two formulations: an intravenous infusion loading dose (130 mg/26 mL) and the subcutaneous injection maintenance dose (90 mg/mL) every eight weeks.
Will uptake for the first ustekinumab biosimilar be as stunted as that for adalimumab? So far, there are few signs that the situation will be different. We’ll be keeping a close eye on the evolution of this market.
Beyond Pavblu, Will Other Aflibercept Biosimilars Launch in 2025?
Amgen launched Pavblu, its biosimilar to Eylea at risk in October 2024, and at least three competitors have received approval. Regeneron has not yet yielded in its legal battle to keep the other competitors off the market. However, Amgen’s launch may force the reference manufacturer to settle with the other aflibercept biosimilar makers. If not, Amgen’s 15% discount in wholesale acquisition price may not be a strong enough inducement for providers to switch agents in this $6 billion US market.
Denosumab: The Floodgates Could Open in the First Half of 2025
The first denosumab biosimilar is scheduled to launch May 31, 2025, based on Sandoz’s agreement with Amgen, the reference manufacturer. After the launch of Sandoz’s Wyost and Jubbonti (biosimilars of Prolia and Xgeva, respectively), there is some uncertainty in the market. The main patent expiration is in February 2025, and several launches are expected. Yet, Sandoz remains the only FDA-approved treatment (at least 4 applications are pending at FDA, and several other manufacturers have completed phase 3 trials).
Eculizumab Biosimilar Launch in March
Amgen will begin marketing its biosimilar to Soliris in March, and Samsung Bioepis also has an approved product, which should launch in 2025. Despite its approval for a rare disease, the US revenues for the reference product is approximately $2 billion.
The Demise of Interchangeability?
Interchangeability has been the bane of the FDA and a source of confusion for payers, providers, patients, and biosimilar makers. The designation has not been utilized in any meaningful way to increase the uptake of pharmacy benefit–covered biosimilars.
A new report in the Pink Sheet casts doubt on the ability of FDA to quickly release a new guidance on the issue of first interchangeability exclusivity.
A guidance released in 2024 by FDA doubted the need for switching studies to obtain an interchangeability designation, and the agency itself has asked Congress to remove the designation altogether. Hopefully, in 2025, the new administration will relegate biosimilar interchangeability to the past.
What Is Less Likely to Occur This Year?
Although there have been some signs that the Trump administration will continue to pressure pharmacy benefit managers to increase transparency and reduce the influence of rebates on coverage decision making, there is little reason to be hopeful this will be resolved in 2025. The drive to streamline biosimilar development continues to gain momentum, and FDA seems to support this evolution. There are several aspects to this effort, including the adoption of a global reference product comparator and the deemphasis on large comparative efficacy studies. Progress will likely be made in 2025 on these issues, but full resolution may take a bit longer, I’m afraid. The faster changes can be made, the better the chances for long-term biosimilar sustainability.
