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Partnerships The United States Food and Drug Administration

Celltrion/Teva and Amgen/Allergan Announce FDA Submissions for Proposed Biosimilars of Herceptin®

by Goodwin on

Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast...more

FDA accepts Celltrion/Teva BLA for biosimilar of Rituxan®

by Goodwin on

Celltrion and Teva announced today that the FDA has accepted for standard review their BLA for CT-P10 and that regulatory action is expected in the first quarter of 2018. CT-P10 is a proposed biosimilar to Rituxan®...more

IRS Office of Chief Counsel Treated Collaboration Arrangement as Partnership

by McDermott Will & Emery on

In a newly released Chief Counsel Advice, the Internal Revenue Service (IRS) Office of Chief Counsel treated a collaboration arrangement relating to the development and commercialization of a drug as a deemed partnership for...more

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