Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment.

Background: SB3 has been developed as a trastuzumab biosimilar, a therapeutic monoclonal antibody targeted to human epidermal growth factor receptor 2 (HER2), and approved by the European Commission and United States (US) Food and Drug Administration (FDA). During the developmental period of a biosimilar, setting an appropriate quality target is critical for assessing the similarity of the biosimilar product to the reference product. A stepwise approach should be taken to assessing similarity, beginning with extensive characterization of the reference product to establish the quality target.

Nanoparticle approaches to combating drug resistance.

Multidrug resistance (MDR) among cancer cells is a serious impediment to the success of conventional chemotherapy. The emergence of nanomedicine demonstrates great promise in overcoming MDR through multiple mechanisms. Nanoparticles have been shown to overcome the MDR at the tissue level through increased intratumoral accumulation resulting from enhanced permeation and retention, neovascular cell targeting, and externally triggered local drug release.

Controlled release of free doxorubicin from peptide-drug conjugates by drug loading.

Covalent modification of a drug with a peptide moiety has been extensively used as an effective strategy to improve the drug's therapeutic outcome. One important consideration in the design of such a prodrug is the release of the free drug from the covalently bound form in a desired fashion. In most cases, the free drug release rate is controlled by the use of various chemical linkers that bridge the drug to the auxiliary segment.