Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2023

Month: February

Request Number: A-2018-000318

Request Summary: New drug submissions filed by Samsung Bioepis Co. Ltd. for its adalimumab product named HADLIMA. The NDS nos. are 203250 and 203292. It is our understanding that all applications initiated by Abbvie Corporation and Abbvie Biotechnology Ltd. prohibiting the Minister of Health from issuing notices of compliance to Bioepis for these new drug submissions have been discontinued. Module 1, excluding the following: 1.2.3, 1.2.4.2, 1.2.5, 1.2.8, 1.3, 1.6, 1.7.

Disposition: Disclosed in part

Number of pages: 700

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