Source: https://www.bioloquitur.com/amgen-v-sandoz-what-shall-biosimilar-applicants-do/
Timestamp: 2019-04-26 14:15:56+00:00

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Home » Amgen v. Sandoz: What “Shall” Biosimilar Applicants Do?
Amgen v. Sandoz: What “Shall” Biosimilar Applicants Do?
On July 21, 2015, the Federal Circuit issued its decision in Amgen v. Sandoz in-terpreting two key provisions in the Biologics Price Competition and Innovation Act (BPCIA).1 The case involved Sandoz’s Zarxio, a biosimilar drug to Amgen’s Neupogen and the first approved abbreviated biologics license application (ABLA) under the provisions of the BPCIA. Judges Newman, Lourie, and Chen were on the panel.
1 Amgen Inc. v. Sandoz Inc., No. 2015-1499, 2015 WL 4430108 (Fed. Cir. Jul. 21, 2015).
2 42 U.S.C. § 262(l)(2) (2013) (emphasis added).
3 42 U.S.C. § 262(l)(9)(C) (2013) (emphasis added).
5 Amgen, 2015 WL 4430108, at *5.
11 Id. at *17 (“Such obligation is mandatory.”).
12 42 U.S.C. § 262(l)(8)(A) (2013) (emphasis added).
13 Amgen, 2015 WL 4430108, at *7.
16 E.g., 42 U.S.C. § 262(l)(3)(B)(ii)(I), (l)(3)(C) (2013).
17 See id. at *8.

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