Wezlana, First Stelara Biosimilar To Hit the Market, Available Only Through Optum's Nuvaila

Without a lot of fanfare or a news release, Wezlana (ustekinumab-auub), the first Stelara (ustekinumab) biosimilar has hit the market but only through a biosimilar procurement business of Optum, a division of UnitedHealth Group.

An Optum spokesperson said in an email to Managed Healthcare Executive this morning that Nuvaila has exclusivity to Wezlana. Nuvaila is a biosimilar procurement business similar to CVS Health's Cordavis and Cigna/Express Scripts' Quallent. AIS Health reported on the exclusive arrangement with Nuvalia earlier this month.

“We have not seen this before,” Jeff Casberg, RPh, M.S., senior vice president clinical pharmacy of IPD Analytics and a member of the Managed Healthcare Executive editorial advisory board, said of the exclusive arrangement. PBM-affiliated biosimilars are new in general, Casberg said, "so this distribution channel is still evolving.”

Amgen, the maker of Wezlana, did not respond to emailed questions.

Starting Jan. 1, a high- and low-list price version of the Stelara biosimilar (ustekinumab) has been available on Optum Rx's commercial pharmacies, according to an Optum Rx spokesperson.

Casberg said the high wholesale acquisition cost (WAC) priced version is priced at 5.5% less than Stelara while the low WAC priced version is priced at 81% less than its brand-name counterpart. Biosimilars are often marketed at two prices, which gives payers the option of paying the higher list price but making up the difference between the high and low price by collecting a rebate from the manufacturer.

Wezlana, an Amgen product, is one of seven biosimilars that the FDA has approved and apparently the first to hit the market, albeit in a limited way.

There is often a significant lag between approval and launch dates for biosimilars because the biosimilar manufacturers negotiate launch dates with the manufacturers of the brand-name reference product as they resolve patent issues. Stelara is manufactured by Johnson & Johnson. It has been a major revenue source for the company and had annual sales of just over $10 billion in 2024. Biosimilar competition this year is likely to cut into those sales either directly or by pushing Johnson & Johnson to offer discounts and rebates to hang on to market share for one of its top selling products.

Wezlana is interchangeable with Stelara, which means it can be substituted for Stelara at the pharmacy-level without the prescriber getting involved. State pharmacy laws can, however, create rules that affect interchangeability. Wezlana, like Stelara, is approved to treat the following indications: moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; and moderately to severely active ulcerative colitis.