BioRationality: A Dr Sarfaraz Niazi Column—The Unmined Treasure of Ignored Biosimilars

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Lurking behind the rat race of taming the 9 molecules in the United States and 14 in the European Union, there are many great opportunities to introduce biosimilars, just as lucrative. Of these, excluding protein-based vaccines and diagnostics, there are 29 monoclonal antibodies, 22 are enzymes, and the rest are of various structures and functions.^[1]

The FDA has approved 41 biosimilars and the European Medicines Agency has approved 71 (shown as US/EU approval count); adalimumab (10/8); bevacizumab (4/8); epoetin alfa (1/5); etanercept (2/3); filgrastim (3/7); follitropin alfa (*2/2); infliximab (4/4); insulin aspart (0/2); insulin glargine (2/2); insulin lispro (0/1); pegfilgrastim (6/8); ranibizumab (2/1); rituximab (3/4); somatropin (x/1); trastuzumab (5/6). [*not under 351k]

There are 621 FDA-licensed biologics products,^[2] including more than 250 recombinant therapeutic proteins,^[3] most of which have no patent protection. A global view shows that in 2019 essential World Health Organization biological drugs include: adalimumab, certolizumab, etanercept, golimumab, infliximab, trastuzumab (as biosimilar), and rituximab. These should be excellent targets for global distribution.

The FDA has issued a list of Essential Medicines in response to a presidential order. The biological products include—filgrastim, insulin, insulin glargine, pegfilgrastim, sargramostim, obiltoxaximab, andexanet, inmazeb, octreotide, raxibacumab in this list.^[4] Shouldn't there be an FDA incentive to ensure the availability of these biosimilars?

Here is my list of biosimilars that make a great choice, getting out of the herd race. (Table).

References

[1] Dimitrov DS. Therapeutic proteins. Methods Mol Biol. 2012;899:1-26. doi:10.1007/978-1-61779-921-1_1

[2] Fact sheet: FDA at a glance. FDA. Updated August 17, 2022. Accessed December 19, 2022. https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance

[3] Usmani SS, Bedi G, Samuel JS, et al. THPdb: database of FDA-approved peptide and protein therapeutics. PLoS One. 2017;12(7):e0181748. doi:10.1371/journal.pone.0181748

[4] Executive order 13944 list of essential medicines, medical countermeasures, and critical inputs. FDA. Updated May 23, 2022. Accessed December 19, 2022. https://www.fda.gov/about-fda/reports/executive-order-13944-list-essential-medicines-medical-countermeasures-and-critical-inputs