Wednesday, 01 Apr 2020

You are here

The Shame Behind Adalimumab Biosimilars

JAMA has a viewpoint article this week on the derailing of the change from biologic drugs to less expensive biosimilar agents. The example is best represented by the opportunity lost in moving from adalimuamb - with nearly $19 billion in sales in 2018 - to any one of the four FDA approved adalimumab biosimilars (see the daily download for slides on new adalimumab and other biosimilars).

There are now 23 approved biosimilars in the United States, with 11 approved for use in rheumatology. This includes:

  • Etanercept biosimilars:  Erelzi (FDA approved 8/16) and Eticovo (4/19)
  • Infliximab biosimilars:  Inflectra (4/16), Renflexis (5/17), and Ixifi (12/17)
  • Adalimumab biosimilars: Amjevita (9/16), Cyltezo (8/17), Hyrimoz (10/19), and Hadlima (7/19)

In Europe, biosimilar adalimumab products have been in wide use with discounts of 80% off the price of brand-name Humira.

Yet large biosimilar discounts are not available in the United States. In the case of Humira, AbbVie (the manufacturer) and the biosimilar manufacturers were embroiled in legal patent disputes until a settlement was reached and each of the new biosimilars settled, agreeing to delay their US launch until 2023. A similar course has been negotiated between the makers of Enbrel (Amgen) and the patent litigants for the 2 etanercept biosimilars.

It's unclear how relevant the 2023 availability of biosimilar adalimumab (or etanercept) will be when other highly effective oral DMARDs or biologics will be available in a changing marketplace. Moreover, in the course of developing newer biologics or JAK inhibitors (for RA, psoriasis, PsA, etc) many of these newer agents will have gone head to head against adalimumab, with some being shown to be more effective that the TNF inhibitor. 

The authors speculate on the availability of oral version of adalimumab (i.e., RaniPill [from Rani Therapeutics]).

The promise of biosimilar cost savings has only played out to some extent (in the USA) with the infliximab biosimilars. In the least the availability of biosimilars Inflectra and Renflexis has lead to price stabilization, instead of the deep discounts like that seen in Europe. Nonetheless, there still are many who hope to substantially reduce the price of biologics for the growing number of potential biologic users. 

When biosimilars for adalimumab or etanercept become available, there will be other challenges regarding rebate strategies, product substitution, patent disputes, marketing and who benefits from price reductions.

Despite the major push to develop new biosimilars in the US, it appears these efforts have done little to reduce the cost of care or increase access to newer and better medicines. 

Isn't this just shameful?

The author has received compensation as an advisor or consultant on this subject

Rheumatologists' Comments

Rapacious pharma helping to destroy lives for more emoluments

More Like This

Start with Anti-TNF in RA? Not So Fast

The suggestion to hit rheumatoid arthritis (RA) early and hard with biologic therapies itself took a hit in a new study.

Use of first-line etanercept (Enbrel) plus methotrexate in very early RA was not associated with a substantially higher rate of remission compared with a strategy of treat-to-target methotrexate monotherapy, a randomized open-label trial found.

Best of 2019 - The Shame Behind Adalimumab Biosimilars

JAMA has an article this week on the shift from biologic drugs to less expensive therapeutic biosimilar agents. The impact of biosimilars can be easily represented by the shift from adalimuamb - a biologic with nearly $19 billion in sales in 2018 - to any one of the four FDA approved biosimilars for adalimumab (see the daily download for slides on new adalimumab and other biosimilars).

Psoriasis Risk Increased with TNF Inhibitors in Juveniles

Children with inflammatory diseases who were treated with tumor necrosis factor (TNF) inhibitors had a higher rate of incident psoriasis than those not exposed to these biologics, a single-center retrospective study found.

Pain Persists Despite TNF Inhibitor Use

Control of pain in patients with rheumatoid arthritis (RA) often focuses on control of inflammation as a means to better control pain. However, a new claims data study shows that while anti-tumor necrosis factor inhibitor (TNFi) may lower the use of opioids, the reduction is nominal, suggesting that a substantial amount of pain is not adequately addressed by TNFi - a potent anti-inflammatory approach.

Adalimumab and Pregnancy Outcomes

A prospective study of birth outcomes to mothers exposed to adalimumab (ADA) between 2004 and 2016 was conducted by Organization of Teratology Information Specialists (OTIS) Research Center at the University of California San Diego, and showed that ADA exposure was not associated with an increased risk for any of the adverse outcomes examined.