Novartis Leads Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Novartis.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, January 10, 2017 to Tuesday, January 16, 2017.
FDA Accepts Novartis’ BLA for Biosimilar to AbbVie’s Humira
The US Food and Drug Administration (FDA) has accepted from Sandoz, the generics arm of Novartis, a biologics license application for a proposed biosimilar to AbbVie’s Humira (adalimumab). Humira had 2016 revenues of $16.08 billion.
Adalimumab is indicated for treating a number of inflammatory diseases, including rheumatoid arthritis, plaque psoriasis, Crohn’s disease, and ulcerative colitis.
There are other recent FDA approvals of Humira biosimilars. Boehringer Ingelheim’s Cyltezo (adalimumab) was approved by the FDA in August 2017. In September 2016, Amgen received approval from the FDA for its Humira biosimilar, Amjevita (adalimumab-atto), across all eligible indications of the reference product.