Biosimilars for the treatment of infectious diseases: the case of biosimilar interferons.

Biopharmaceuticals are the fastest-growing and the most expensive among prescription drugs. A biopharmaceutical drug can cost a patient between USD 25,000 and USD 120,000 a year. Such sophisticated medicines are critical options for many unmet medical needs where no sufficient therapies are available, and the demand for lower-cost biopharmaceuticals is tremendous. Biosimilars are similar to, but not the same as, innovative biopharmaceuticals. Since they are developed following patent expiration of innovative medicines, biosimilars represent a potentially lower-cost option to patients and healthcare providers. With a broad range of biopharmaceuticals going off patent, the biosimilars field became the focus of attention of drug developers, healthcare providers, patient advocate groups and politicians. Regulatory and marketing issues for biosimilars have been discussed in several recent reviews. The main focus of this article is the scientific spects of interferon-α biosimilars and next-generation interferons for the treatment of hepatitis C.