AJMC November 11, 2021
There is now a mad scramble to gain interchangeable status for biosimilars, but the meaning and significance of this appellation haven’t yet been worked out for health care consumers or the manufacturing community.
In July 2021, the FDA approved an insulin glargine drug as not only a biosimilar but also the first “interchangeable,” meaning pharmacists could use their own discretion in dispensing this product to patients without having to seek provider authorization. It was then that things started to happen for this drug (Semglee), which had previously been available as an equivalent to Lantus, the reference product, but was not considered a biosimilar.
The biosimilar status, which was applied for by Biocon Biologics and Mylan, represented FDA certification that the...