On January 12, AbbVie announced that it had reached an agreement with the Trump administration on participation in its most favored nation (MFN) pricing initiative, and making certain medications available through its direct-to-consumer platform.

With the various agreements made with 15 other pharmaceutical companies, specific drugs were not disclosed. This is the first time in the short history of the MFN initiative that it involves a reference product with active biosimilar competition—that is, of publicly disclosed information.

However, the MFN (and Medicare maximum fair price for that matter) programs were explicit in their intent to avoid interfering with the biosimilar and generic marketplaces. For their part, AbbVie may simply be seeking another access channel to forestall fading Humira volume. It is not expected that the TrumpRx direct-to-consumer channel would be particularly strong.

What Is the MFN Price of Humira Likely to Be?

What would be the MFN price of Humira? Data on which the calculation derived from the administration’s international pricing index of countries with comparable economies are a bit dated, and the source has not been verified. Based on 2023 prices, Humira pricing ranges from $875 per 40 mg dose in Italy to $316 in France (of countries included in the MFN international index). Many of the adalimumab biosimilars are already providing deep discounts (some greater than 85%), to a price range of $450 to $693 for the same dose. At least one biosimilar is available through Mark Cuban’s Cost Plus at a 92% discount. What AbbVie offers under TrumpRx is unknown, but for cash paying buyers, Humira monthly cost will likely be hundreds of dollars, and largely unaffordable for most.

The point is that the biosimilar industry needs no additional impediment to its success, and most certainly, not in the adalimumab category. The reference product still retains the largest market share, and several adalimumab biosimilar makers are hanging on with miniscule volume.

In its rush to make TrumpRx MFN deals, the administration seems to have run roughshod over its own stated intention, to protect the biosimilar segment from harm. Simply, did AbbVie seek to include Humira in the arrangement, and the administration paid inadequate attention? Or did the administration seek to include Humira because of its boldface status, which would have been even stranger?

A Lack of Foresight or Lack of Principles?

Either way, this move sends a signal that the administration is conflicted about signing MFN deals for other reference drugs with active biosimilar competition. This isn’t an unintended consequence of the MFN policy; it’s a self-inflicted wound.

My original worry was that MFN, like Medicare’s maximum fair price negotiations, will discourage investment in biosimilar development. This was a problem for prospective biosimilar developers, I thought, not those with existing, approved biosimilars.

This seeming misstep is likely the result of the same “move fast and break things” mentality that has characterized this administration from the beginning of its second term. This was not a deeply considered move.

This article was written by our Director of Content, Stanton Mehr. Stan is has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 12 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. 

Here’s a question that has been asked repeatedly over the last year or so: Does it make sense to have private label medical benefit-covered biosimilars?

We’ve seen the spread of private-label or “white-label” biosimilars, by the big 3 pharmacy benefit managers (PBMs) specifically, for adalimumab and ustekinumab. Although we’re not sure of current market utilization of the private-label versus non–private label products, we do know that the availability of the private-label products helped biosimilars on the road to uptake if not financial success.

We have in our sights some major medical benefit–covered reference products losing patent protection and marketing exclusivity over the next few years. These include Keytruda, Opdivo, Yervoy, Perjeta, and Ocrevus to name a few. All are high-cost agents that are important (if not critical) to patient care.

The discussion of a medical benefit private-label biosimilar must tease out the potential advantages/disadvantages for both the manufacturer and the provider (who in a buy-and-bill situation makes the initial prescribing decision) or payer (who decides on coverage/reimbursement). The first assumption is that PBMs generally deal far less with specialty drugs under the medical benefit (and especially oncology drugs). By their very name PBMs manage the pharmacy, not the medical, benefit. However, their affiliated specialty pharmacies are in a viable position to play an influential role, via white bagging. If that is the case, the provider’s buy-and-bill initiative would be lost, and they would be reimbursed solely for administration services. For PBMs, earning additional dollars through their specialty pharmacy, such white-labeled products seems highly promising.

The second assumption is that heavy competition at launch for medical benefit–covered biosimilars like Keytruda will result in huge, immediate net price discounts, as seen with the highly contested adalimumab and ustekinumab biosimilar launches. Competition is competition, regardless of how a drug is covered, so this is reasonable. The bigger question is whether Medicare price negotiation or most favored nations pricing hits before biosimilars launch (they shouldn’t, according to official and draft policy, but we should account for this anyway). A lower list price will mean lower cost savings for biosimilars.

A payer might be more neutral on the private-label issue. In general, private labels have not spelled greater net savings over low-WAC biosimilar versions of adalimumab or ustekinumab. They don’t seem to be extremely motivated to insist on non-private-label versus private-label biosimilar coverage. On the other hand, plan sponsors may think otherwise, based on the call for more PBM transparency. If the PD-1 inhibitor biosimilars, for instance, were available by private label through the specialty pharmacy, it would probably have little effect on payers except reducing buy-and-bill transactions for those specific products.

With the introduction of eight new Keytruda biosimilars competing for a $30 billion US market, discounts will quickly increase—regardless of MFP or MFN pricing. It should mean a virtual (delayed) free fall in average sales pricing (ASP), which will further dissuade providers from wanting to purchase these products and take on the risk of being caught underwater. If this follows, it drives purchases and distribution through the specialty pharmacy. Will the PBMs jump at the opportunity? Are there wholesaler or other relationships that they do not currently have to be in established first?

I don’t know the answers. I hope these thoughts spur a considered discussion of the advantages and disadvantages, and where this concept leads. Please lend your voice and comment on this topic.  

This article was written by our Director of Content, Stanton Mehr. Stan is has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 12 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.