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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?