FDA approves the first interchangeable biosimilar of adalimumab from Boehringer Ingelheim

On October 18, the FDA announced the approval of Boehringer Ingelheim’s adalimumab analog Cyltezo as an interchangeable biosimilar of AbbVie’s Humira.
This is the first adalimumab approved by the FDA.
Exchange biosimilar drugs
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This approval means that when Cyltezo is on the market, pharmacists can use Boehringer Ingelheim's product to replace AbbVie's Humera without a doctor's re-prescription

From: FDA official website

Compared with biosimilars, interchangeable products, under the same conditions as the clinical efficacy of the original biopharmaceuticals, also need to pass relevant tests to prove that after at least two clinical drug exchanges, they will be compared with the original biosimilar.

Therefore, a product approved as an interchangeable product means that the FDA has concluded that it can substitute the reference drug without consulting the prescriber
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For example, suppose a patient treats their rheumatoid arthritis by self-administered injection of a biological product

Boehringer Ingelheim’s Cyltezo is the first product to report interchangeable clinical trial results
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In the VOLTAIRE-X study, patients in the switching treatment group switched to the BI 695501 drug candidate in the switch group at week 14, returned to the adalimumab reference product at week 18, and then returned to BI 695501 at week 22

In the field of adalimumab biosimilar drugs, the current leader is Amgen’s Amjevita (adalimumab-atto), which is likely to be launched in January 2023; other products include Sandoz’s Hyrimoz (adalimumab-atto).
Anti-adaz), Pfizer's Abrilada (adalimumab-afzb) and Samsung's Hadlima (adalimumab-bwwd) have been approved and will be available later in 2023
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So far, the FDA has approved two interchangeable biosimilar drugs
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On July 29, 2021, the FDA approved the first interchangeable biosimilar drug, Semglee (insulin glargine-yfgn) from Viatris