29 new biosimilar drugs were approved by the Food and Drug Administration (FDA) in the United States over the past five years. This trend does not appear to be slowing down any time soon and even more biosimilars are expected for the remainder of 2024 and beyond. More specifically, when it comes to patients living with inflammatory conditions, the market expects to launch three additional biosimilars to Stelara (ustekinumab – Janssen), which are outlined below.
Biosimilars for inflammatory conditions
Amgen’s first biosimilar to Stelara, WEZLANA, was approved on October 31st, 2023 and is expected to launch any time before Jan 1st, 2025. WEZLANA is indicated for the treatment of plaque psoriasis for adults and children 6 years and older as well as for psoriatic arthritis, Crohn’s disease and ulcerative colitis. The biosimilar was also approved with an interchangeability designation, allowing it to substitute for Stelara at the pharmacy level without requiring a pharmacist to get permission from a provider first. This designation is intended to increase access to the biosimilar and convenience for patients, who often have to wait long periods of time to obtain a medication because they have to wait for provider approval.
The second biosimilar to Stelara, SELARSDI, was FDA-approved on April 16th, 2024. SELARSDI is a human interleukin-12 and -23 antagonist and, similar to WEZLANA, is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. SELARSDI is expected to be marketed in the U.S. on or after February 21st, 2025, following a settlement agreement with Johnson & Johnson, the manufacturer of Stelara.
A third biosimilar to Stelara is expected to be FDA-approved in September of this year and will likely launch in 2025.
Leveraging competition to drive savings
Biosimilar availability in the U.S. has been slow, largely due to ongoing patent litigation with manufacturers. We estimate that the competition created with biosimilars can deliver $225 billion to $375 billion for plan sponsors in drug cost savings by 2031.
Over the years, we have seen how competition works quickly and effectively to lower drug prices and keep price increases in check. For example, the list price of Lantus, a long-acting insulin injector, more than doubled during the five years after it was approved in 2010, until competing products entered the market in 2015. Following the entry of several biosimilar options — including an interchangeable option — the price for Lantus decreased. In turn, plan sponsors were able to apply those savings to lower premiums, expand medication lists, fund wellness programs, or pass savings directly to patients at the pharmacy counter.
Considerations for plan sponsors
Plan sponsors can encourage the use of clinically sound, cost-effective products by:
- Educating members about the safety, efficacy and cost benefits of biosimilars.
- Offering financial incentives for biosimilars such as reduced co-pays.
- Partnering with pharmacies that have clinical support programs in place to support patient adoption of biosimilars.
Looking ahead
Biosimilars for inflammatory conditions have the potential to reshape the specialty medicine landscape. By the end of 2024, these medicines have the potential to drive additional market competition with existing biologics and specialty medications that represent half of the current spending on inflammatory conditions like rheumatoid arthritis.
Based on this, the outlook for biosimilars is still promising as ever.
Originally published on 6/30/2023 and updated on 7/1/2024.
