Marketed PEGylated Drugs Approved by FDA and in Europe

An excellent review article is published by scientists from Nektar Therapeutics, Bayer, Jansen, and Baxalta Innovations GmbH in the journal of Journal of Pharmaceutical Sciences.

http://dx.doi.org/10.1016/j.xphs.2015.11.015

Journal of Pharmaceutical Sciences 105 (2016) 460-475

“PEGylation of Biopharmaceuticals: A Review of Chemistry andNonclinical Safety Information of Approved Drugs”.

Since 1990, 12 PEGylated biopharmaceuticals have been introduced into the market place as drugs for human use (Table 1).Eleven are PEGylated protein biopharmaceuticals and one is aPEGylated aptamer (Macugen) administered intravitreally. Adagen®, Krystexxa®,

Neulasta®, Oncaspar®, PEG-Intron®, Somavert®, and Plegridy® are PEGylated with PEG molecules having molecular weight of 5-20kDa. Cimzia®, Macugen®, Mircera®, Omontys®, and Pegasys®are PEGylated with PEG molecules of 30 or 40 kDa.

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