Pharmacovigilance for 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

Biosimilars: potential implications for clinicians

With the expiration of patent protection for several biologics looming, the production of highly similar therapeutic agents has begun to emerge on the pharmaceutical market. These alternative drugs are referred to as biosimilars. Many anticipate that the introduction of these agents will result in a reduction in health care costs, which may create a more affordable biopharmaceutical market and ...

Biosimilars: new promise for reducing healthcare costs

After much anticipation, approval of the first U.S. biosimilar medications may be around the corner. Biosimilars hold the promise of reducing healthcare spending by offering lower-cost alternatives to highpriced biologic drugs. Biosimilars are not generic versions of existing biologics, however. Generic medications contain an active ingredient identical to that in the reference (‘‘brandname’’) ...