Vaskulárna medicína 1/2015

Biosimilars – generic copies of various types of biotech drugs?

Biologics play an integral role in the treatment of cancer not only for their therapeutic effects and ability to improve outcomes, but also as supportive care agents. Biologics are more complex to manufacture and take longer to bring to market. Biologics are considerably more costly than small-molecule drugs. Their use has placed an increasing economic demand on healthcare systems worldwide. Biosimilars are designed to be highly similar to existing branded biologics, but because biologics cannot be exactly copied, biosimilars should not be referred to as generic. Regulatory requirements for biosimilars are evolving, as are global harmonization and/or standardization treatment strategies. This article highlights critical factors involved with the integration of biosimilars into oncology treatment practices.

Keywords: biologics, biosimilars, generics, safety.