Teva received an appellate court ruling suggesting that CMS did not have authority from Congress to define a bona fide marketing standard for its IRA Medicare Fair Price negotiations. How does this relate to products targeted for IPAY negotiations and biosimilar competitors?
This week, Teva received an appellate court ruling on the IRA Medicare Fair Price (MFP) question as to whether a generic drug (or biosimilar) is to be considered a “bona fide” marketed product. This gets to the very heart of whether the reference product or originator brand is eligible for the MFP IPAY negotiations in the first place.
In Teva’s case, the DC Appellate Court ruled that the challenge to the Centers for Medicare and Medicaid Services definition of bona fide marketing is valid. In its decision, the Court stated, that CMS will consider a generic as marketed “only when the manufacturer engages in ‘bona fide marketing.’ Teva says both rules exceed CMS’s statutory authority and that the Negotiation Program deprives it of a protected property interest without due process. The Government responds that the IRA bars courts from reviewing Teva’s statutory claims. Teva’s challenge to the ‘bona fide’ marketing requirement, however, is ripe for review.”
Whereas the appellate court did not rule on the merits of Teva’s challenge to the definition, it sent the question back to the District Court with the explanation that the IRA legislation did not give CMS the authority to make this determination.
IRA MFP Controversy From the Beginning
CMS decided that ustekinumab should be eligible in the first round of IPAY negotiations, despite the large number of approved biosimilars scheduled to launch prior to the implementation of its MFP-negotiated price (January 1 2026). In November 2025, CMS decided to delist ustekinumab, in the face of active biosimilar competition, though the MFP pricing ($4,695 per 30-day supply) will apply through January 1, 2027. The current WAC cost for Stelara is down to less than $500 per month. In other words, CMS is overpaying (by a lot) this year for ustekinumab.
In the case of etanercept, it was also included in the first round of Medicare price negotiations, despite two US FDA approved biosimilar products but no expectation for launches before 2028, owing to patent extensions of dubious justification. For Enbrel, the implementation of MFP discounts makes a lot of sense, despite the likely lost future revenues by the biosimilar manufacturers.
This points to the unpredictability and challenges of evaluating potential patent settlements and launch agreements with reference manufacturers. We are already seeing the potential for this to affect Keytruda, Opdivo, and other big-ticket biologics with significant upcoming biosimilar competition.
What Is Bona Fide Marketing?
Another interesting point related to the bona fide marketing requirement is that even if a biosimilar product is approved and marketed, there is no guarantee that the manufacturer will enter into large marketing programs as are commonly seen for reference or branded products. Typically, especially on the generic side, marketing budgets are relatively low end; the manufacturers may rely on automatic substitution heavily to gain prescription volume. This consideration seems to be outside of CMS’s thought process. Personally, I’ve seen only limited traditional marketing efforts on the part of biosimilar manufacturers several specific products.
This brings us back to the original question of whether CMS has the best standard for gauging the expected launch date of a generic or biosimilar at the time it produces its list of IPAY targets for the current year. We’ve seen no evidence that there is a consistent bar or protocol through which these decisions are made. Yet, these decisions may be crucial for prospective biosimilar manufacturers and for CMS itself—biosimilars with adequate competition will always produce greater discounts and lower prices than IPAY negotiations. Notwithstanding the ability of CMS to delist in the future a product that has been exposed to biosimilar competition, if it doesn’t change its view towards eligibility of reference products, CMS will continue to waste time negotiating pricing on products that will be delisted within a year of implementation. More importantly, it would lose the opportunity to save billions of dollars from biosimilar competition for the year before delisting. And isn’t saving money what this exercise is all about?
This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.