echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > Boehringer Ingelheim's monoclonal antibody Cyltezo obtains first bio-interchangeable drug license

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

    • Last Update: 2021-11-04
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

    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.


    Iceland's Alvotech filed a lawsuit against AbbVie and is expected to make a ruling on the case before the end of October next year


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

    Reference source: Boehringer's interchangeable tag for Humira biosim is a'landmark' win for the field: analyst
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.