FDA Approves Amgen’s WEZLANA As Biosimilar to and Interchangeable With Janssen’s STELARA (ustekinumab) – Stelara Is One of the 10 Drugs Selected by CMS for Drug Price Negotiations Under the Inflation Reduction Act

On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab).  WEZLANA is the first product to be approved as a biosimilar to STELARA.  As we covered previously, Janssen and Amgen settled their BPCIA litigation regarding Amgen’s ustekinumab biosimilar product in May 2023.

The licensure and marketing of WEZLANA could affect negotiations with CMS regarding Medicare pricing for STELARA under the Inflation Reduction Act’s Drug Price Negotiation Program.  As we covered previously, STELARA was one of the 10 drugs selected by CMS for the first year of IRA Drug Price Negotiations, and Janssen (along with every other manufacturer whose drugs were selected for the Program) has agreed to participate in the Program to “negotiate” a “maximum fair price” for their respective selected drugs.   For drugs selected for the first year of the Program, negotiations will end by August 1, 2024.  The final “maximum fair price” will be published by September 1, 2024, and manufacturers must “provide access” to the drug to Medicare beneficiaries at a price no higher than the “maximum fair price” beginning January 1, 2026.

Depending on its timing, the future launch of WEZLANA could cause STELARA to be “deselected” from the Program before a “maximum fair price” (MFP) is “negotiated” or before it takes effect.  Under the IRA, drugs selected for the Program remain “selected drugs” until HHS determines that there is at least one product that is both “approved or licensed” as a generic or biosimilar of the selected drug and “marketed pursuant to such approval or licensure.”  CMS has stated in guidance that to determine whether a biosimilar (or generic) is “marketed,” it will look at the “totality of the circumstances,” including Part D and Medicaid data for the biosimilar over a rolling 12-month period, to determine whether the manufacturer of the biosimilar is engaged in “bona fide marketing” of the product.  CMS will review this data on a monthly basis after FDA has licensed the biosimilar to determine if the manufacturer is actually engaged in “bona fide marketing.”  (CMS’s position on this has been challenged in pending litigation.)  According to a reported statement from Amgen, its settlement agreement with Janssen allows Amgen to sell WEZLANA “no later than January 1, 2025.”

According to CMS guidance, if CMS makes the decision that a biosimilar like WEZLANA is subject to “bona fide marketing” before August 1, 2024 (the date the MFP negotiations end for price year 2026), the selected drug (STELARA) will remain a selected drug for price year 2026 (but the MFP would not apply).  In that case, according to CMS’s guidance, STELARA would cease to be “selected” on January 1, 2027.  If CMS decides between August 2, 2024 and March 31, 2026 that WEZLANA is both approved and subject to bona fide marketing, CMS guidance indicates that STELARA would remain a selected drug for price year 2026 (and the MFP, which will have been negotiated, would apply), but would cease to be “selected” on January 1, 2027.  If CMS decides between April 1, 2026 and March 31, 2027 that WEZLANA is both approved and subject to bona fide marketing, CMS guidance indicates that STELARA would remain a selected drug for price years 2026 and 2027 and the MFP would apply for both of those years; STELARA, according to CMS guidance, would cease to be “selected” on January 1, 2028.

FDA’s approval of WEZLANA has also been raised as a pertinent fact in one of the pending challenges to the Drug Price Negotiation Program.  In the PhRMA litigation, brought by PhRMA along with the National Infusion Center Association (NICA) and the Global Colon Cancer Association, the government has cited the recent approval of WEZLANA as support for its pending motion to dismiss.  One of the arguments the government has made in support of its motion to dismiss is that the NICA Plaintiff is the only plaintiff in the case with any relevant connection to the Western District of Texas (where the case was filed) and does not have Article III standing.  In response, one of the arguments the Plaintiffs have made is that NICA’s members will be harmed by the inclusion of STELARA in the Drug Price Negotiation Program.  The government has argued in reply that if a biosimilar to STELARA is approved and launched by early 2025 as has been reported, then “Stelara will be deselected, and negotiated prices will never take effect for the administration of Stelara under Part B.”  Last Thursday, November 2, the government filed a supplemental notice of authority stating that FDA’s approval of WEZLANA “underscores the degree to which Plaintiffs’ standing theory relies on ‘unsupported speculation about harms NICA’s members might suffer ‘no later than 2028,’…which cannot support Article III standing.”  Briefing on the government’s motion to dismiss was completed on October 13, 2023.  The court has ordered that briefing on motions for summary judgment in the case will resume within 14 days of the court’s order on the Motion to Dismiss.

For more information about the Inflation Reduction Act and pending challenges to the Drug Price Negotiation Program, please visit Goodwin’s IRA Resource Page.