Amgen, Daiichi Sankyo Form Biosimilars Pact; Amgen Advances Humira BiosimilarBy
Amgen and Daiichi Sankyo Company, Limited have formed an exclusive agreement to commercialize nine biosimilars in Japan. The deal includes several biosimilars in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab.
Under the agreement, Amgen will remain responsible for the development and manufacturing of the biosimilars. Daiichi Sankyo will file for marketing approval and be responsible for distribution and commercialization in Japan while Amgen will have a limited right to co-promote the products. Amgen will retain all additional distribution and commercialization rights for the biosimilar programs outside of Japan. Specific financial terms of the agreement were not disclosed.
In other news, Amgen will discuss data supporting its biologics license application (BLA) for AP 501 a biosimilar candidate to Humira (adalimumab), an anti-tumor necrosis factor-alpha (TNF-Î±) monoclonal antibody with the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee. During the meeting, Amgen will present a data package which supports biosimilarity of ABP 501 to adalimumab based on analytical, nonclinical, clinical and pharmacokinetic data, including results from two Phase III studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The FDA has set a Biosimilar User Fee Act target action date of September 25, 2016 for ABP 501.
Humira’s was AbbVie’s top-selling drug in 2015 with sales of $14.012 billion. ,