Pegfilgrastim-jmdb/MYL-1401H: A Pegfilgrastim Biosimilar

Author:

Hoy Sheridan M.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Reference7 articles.

1. Mylan GmbH. FULPHILA™ (pegfilgrastim-jmdb) injection, for subcutaneous use: US prescribing information. 2018. http://www.fda.gov/ . Accessed 11 Oct 2018.

2. Mylan S.A.S. Fulphila 6 mg solution for injection in pre-filled syringe: EU summary of product characteristics. 2018. https://www.ema.europa.eu/ . Accessed 12 Dec 2018.

3. Waller CF, Tiessen RG, Lawrence TE, et al. A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim. J Cancer Res Clin Oncol. 2018;144(6):1087–95.

4. Sankaran PK, Palanivelu DV, Nair R, et al. Characterization and similarity assessment of a pegfilgrastim biosimilar MYL-1401H. J Clin Oncol. 2018;36(15 Suppl):e19028.

5. US FDA. Center for Drug Evaluation and Research application number 761075Orig1s000: clinical review(s). 2018. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761075Orig1s000MedR.pdf . Accessed 12 Nov 2018.

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