Boehringer Ingelheim's monoclonal antibody Cyltezo obtains first bio-interchangeable drug license

Boehringer Ingelheim said on Friday that Cyltezo has been approved by the U.
S.
Food and Drug Administration (FDA), and the drug has become the first interchangeable Humira biosimilar
.

At present, even though many biosimilar companies have chosen to reach a patent settlement agreement with Humira manufacturer AbbVie, Boehringer seems to insist on challenging AbbVie's market position
.
According to the company’s patent settlement agreement with AbbVie, Boehringer Ingelheim will not be able to launch Humira generics until July 1, 2023, but the regulatory approval of Cyltezo will mean that pharmacists can use Cyltezo instead of Humira at the pharmacy counter.

So far, every approved biosimilar drug requires a prescription specifically for the biosimilar drug itself
.
Interchangeability means that biosimilar drugs can be regarded as small molecule generic drugs, and Cyltezo can replace its reference brand original drug Humira at will

Cyltezo's approval is also a "milestone achievement" for the entire field, because the therapy is the first interchangeable monoclonal antibody, and most of the drugs targeted by biosimilars are monoclonal antibodies or mAbs
.
The news shows that the FDA has now established requirements for the approval of interchangeable drugs

At the same time, for the Humira market, Gal stated that Boehringer Ingelheim "should not be underestimated" because the company has "important biomanufacturing and commercial capabilities in the US market

However, Boehringer Ingelheim will not be the only company striving for huge market profits with Humira
.
According to the 2017 transaction, Amgen will launch the first Humira biosimilar on January 31, 2023

AbbVie’s blockbuster Humira generated more than $16 billion in revenue in the US market last year
.
But opponents still intend to challenge AbbVie's patent in court.

Reference source: Boehringer's interchangeable tag for Humira biosim is a'landmark' win for the field: analyst