The Diversity of Biosimilar Design and Development: Implications for Policies and Stakeholders

Author:

Grampp Gustavo,Ramanan Sundar

Funder

Amgen Inc.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Reference37 articles.

1. Sekhon BS, Saluja V. Biosimilars: an overview. Biosimilars. 2011;1:1–11.

2. European Medicines Agency. Guideline on similar biological medicinal products. Report no.: CHMP/437/04 rev 1. London: European Medicines Agency; 2014.

3. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. Rockville: US Food and Drug Administration; 2015.

4. Felix T, Johansson TT, Colliatie JA, Goldberg MR, Fox AR. Biologic product identification and US pharmacovigilance in the biosimilars era. Nat Biotechnol. 2014;32(2):128–30.

5. US Food and Drug Administration. Guidance for industry: biosimilars: questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009. Rockville: US Food and Drug Administration; 2015.

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