On November 9, Amgen gave the latest signal of its intention to market a biosimilar to AbbVie’s Humira (adalimumab) by presenting detailed findings from a head-to-head phase III clinical study. The study, presented orally at the 2015 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in…
Momenta and Baxalta have announced a global clinical trial to study the safety, efficacy and immunogenicity of M923, a biosimilar to AbbVie’s Humira (adalimumab). The trial is intended to support regulatory filings in both the U.S. and the E.U. with the goal of launching commercially in 2018. Read more here.
As we’ve covered in previous posts and in the IPR section of this blog, several IPR petitions have been filed against patents relating to the biologic products Humira (adalimumab) and Rituxan (rituximab). The PTAB has now issued decisions on whether it will institute IPR on the three Rituxan (rituximab) IPR…
On Friday, June 26, 2015 Amgen Inc. filed IPR petitions (IPR2015-01514 and IPR2015-01517) against two Humira (adalimumab) patents owned by AbbVie Inc., in an effort to clear the way for its Humira biosimilar, ABP 501. The patents, 8,916,157 and 8,916,158, are directed to improved formulations of Humira, which Amgen argues are…