The Adalimumab Biosimilar Glut Save

In 2023, three marketed biosimilars (Actemra, Stelara, Humira) had their patents expire, opening opportunities for multiple new biosimilars; but with competition comes a word salad of new drug names, confusion and nonsensical discounts.

By July 2023, nine adalimumab biosimilars (ADA-b) have entered the US market to compete with Humira. The 2022 worldwide sales of Humira were estimated to be nearly $22 billion USD. In 2021, the US government spent $9 billion on Humira alone.  With the patent loss and new ADA-b introductions, Humira sales are expected to drop 35% in 2023. 

First to launch was Amjevita (Amgen) in Jan 2023, with 7 others arriving in early July and soon to follow - a 9th ADA-b from Pfizer, Abrilada (adalimumab-afzb); now awaiting an FDA decision on its interchangeability and lower concentration version of ADA.

These ADA-b versions will have the same 11 disease indications as the originator Humira: thereby affecting many rheumatology, dermatology, immunology, and gastroenterology patients.

The full list of current US ADA-b (the generic name and suffix, and manufacturer) includes:

• Amjevita (adalimumab-atto) from Amgen
• Idacio (adalimumab-aacf) from Fresensius Kabi
• Hulio (adalimumab-fkjp) from Biocon Biologics
• Cyltezo (adalimumab-adbm) Boehringer Ingelheim
• Hadlima (adalimumab-bwwd) from Organon and Samsung Bioepis
• Hyrimoz (adalimumab-adaz) from Sandoz
• Yuflyma (adalimumab-aaty) from Celltrion Healthcare
• Yusimry (adalimumab-aqvh) from Coherus
• Abrilada (adalimumab-afzb) from Pfizer

ADA Biosimilar Cost

As of July 203, the wholesale acquisition cost of Humira was $6,922 for a four-week supply (about $83,000 annually).  The next nine ADA biosimilars will be variably discounted. At issue is will the glut of ADA-b availability and competition substantially change the price – a long awaited, but yet to be cashed concept in biosimilar availability.

What is at stake is what percentage of Humira’s market share will these companies gain? Each of the new ADA-b manufacturers are eyeing a 3-5% share of AbbVie’s Income from Humira.

While the ADA-b manufacturers will be cheaper, there are markedly different pricing strategies. For example:

• Amjevita debuted in January 2023 with a 5% and 55% discount to Humira, depending on who was purchasing. This pricing structure was reported to be similar to what Abbvie was offering in 2023.
• Hulio (Biocon) will be listed at 5% and 85% below Humira’s current pricing. Biocon said its 85% discounted Hulio will cost about $12,500 annually.
• Hyrimoz (Novartis) priced at both a 5% discount and 81% discount.
• Hadlima (Organon and Samsung Bioepis) 85% discount
• Cyltezo (BI) will be discounted 5-7%; but will also have a larger discount with availability from Mark Cubans online drug pharmacy.

These high/low discount options have little bearing on net price and are more about different discounts offered to different buyers (PBMs vs non-PBMs) for different purposes. Steeply discounted (80+%) ADA-b are intended for larger health systems not seeking after-market discounts (rebates) as PBMs routinely do. The lower discount price (~5%) appeals directly to pharmacy Benefit Managers (PBMs). With PBMs, 5% discounts are just the beginning of negotiated discounts, to be followed by rebates between the PBMs and manufacturers. These rebates (confidential discount) are bartered to get a specific ADA-b on the PBM’s formulary. These rebate monies are shared between the PBM and insurance company, but not to patients. High priced biosimilars will likely get larger rebates. Those ADA-b that are steeply discounted (>9=80%) will not likely receive any rebate benefits. Rebates don’t benefit patients or pharmacists.

Availability

PBMs will continue to offer Humira as the preferred brand and will add one or more ADA-b options to their formulary. For instance, CVS Caremark will be offering Amjevita as a nonpreferred brand; Cigna will add Hyrimoz and Cyltezo to its formulary; and Express Scripts and Optum chose Cyltezo and Hyrimoz as their additions. 

Three ADA-b (Hadlima, Hyrimoz, and Yuflyma) are available as high concentration adalimumab, the same formulation making up 85% of Humira prescriptions.

Mark Cuban's Cost-Plus Drug Company (a direct-to-consumer model) to will offer Cytelzo (Boehringer Ingelheim) and Yusimry (Coherus Biosciences) to customers at a price of ~$570/month, plus dispensing and shipping fees starting after July. 

Interchangeability

Currently only Cytelzo is FDA approved for interchangeability, but there are several ADA-b pursuing interchangeability. Abrilada is in the process of seeking interchangeability from the FDA. Interchangeability means that a biosimilar can be substituted by the pharmacy.  In the USA, 47 states allow interchangeability where biosimilar can be substituted for the originator (Humira) by the pharmacist without prior approval of the clinician prescriber (but the clinician must be notified of the switch within a certain time frame). In 40 states, patients need to be notified of the switch before substitution. Several companies are pursuing interchangeability.

Biosimilar Business

During the two quarters of 2023 Amgen's Amjevita competed head-to-head with Humira in the US and sold nearly $70 million of Amjevita. But the second quarter of Amjevita sales were down to $19 million, after selling nearly $51 million in the first quarter of 2023.

When infliximab biosimilars (e.g., Inflectra, Renflexis, Avsola) were introduced to the US market in 2016, they initially were priced at 15-30% lower than the originator Remicade. Inflectra was launched at a 19% discount, Renflexis at a 35% discount, and lastly, Avsola launched at a 57% discount compared with the reference product, Remicade. Thus, it appears that with time biosimilar discounts will grow. This certainly has been the case with cancer drugs, were biosimilars bevacizumab and trastuzumab have 85% and 83% market share, respectively and are discounted nearly 25% compared to Avastin and Herceptin.

While biosimilars have lowered the cost of care, there isn’t clear evidence that cheaper biosimilars have led to greater use of biologics.