Pharmacovigilance of Biosimilars

Pharmacovigilance of Oncology Biosimilars

Biologicals are critical in cancer medicine. Four of the top ten biological blockbusters worldwide are oncology drugs used for therapeutic or supportive care. The global market for biologic cancer therapies approximately totalled US$ 51.2 billion in 2014 and is expected to reach US$ 66.4 billion in 2019. The patents of most of these top-selling agents will expire by the year 2020 attracting ind...

Comparative testing and pharmacovigilance of biosimilars.

Unlike traditional generic pharmaceuticals, biosimilars (also called 'follow-on biopharmaceuticals' in the USA) aim to copy a complex recombinant, three-dimensional protein structure with high molecular weight. Small changes in the manufacturing process can alter the product's effect and safety. According to the guidelines of the European Agency for the Evaluation of Medicinal products (EMEA), ...

Biosimilars

Bioanalytical challenges of biosimilars.

Biologics such as monoclonal antibodies and recombinant proteins represent a significant portion of the pharmaceutical market. With many of the first generation biologics' patents expiring, an increasing number of biosimilars will be submitted for approval in the near future. The successful development of a biosimilar requires the demonstration of biosimilarity in terms of efficacy, safety and ...

Coming of Age: Biosimilars.

by Szilard Kiss, MD; and Jennifer Krawitz, MD The 20-year clock on drug patents begins ticking upon the invention of a drug, rather than upon drug approval by the U.S. Food and Drug Administration (FDA). The process of FDA approval is lengthy: pushing a novel medication through phase 1, 2, and 3 trials can often approach 8 or more years. Just over a decade ago, the dawn of the anti-vascular end...