Biologicals and biosimilars: a review of the science and its implications

The future of biological therapy: a pathway forward for biosimilars

“…It is also important to realize that for one product, the risk of immunogenicity may differ depending on the therapeutic indication [6].…”

Terminology for biosimilars–a confusing minefield

“…It has been shown that the quality of different non-innovator/copy products can vary signifi cantly and even different batches of what appears to be the same product can differ, with implications for both effi cacy and safety [10,18,19,20]. It is therefore imperative that clear terminology is used to accurately describe the nature and particularly the regulatory procedure used for particular biologicals.…”

“…Clear guidelines have been produced by the Committee for Medicinal Products for Human Use and its working parties, describing the desired criteria including quality, non-clinical and clinical studies needed for biosimilars and requirements for their regulatory approval in the EU [1][2][3][4][5]20]. The comparability of quality aspects required is signifi cant and some data from such studies have been partially published [6,7].…”

What is your Institution's Position Going to be on Biosimilars?

“…[3][4][5][6][7][8][9][10][11][12][13][14] The definition of "highly similar" is not fully understood by most practitioners and regulators. These compounds are more difficult to produce, and small changes in the manufacturing process (eg, type of expression system, changes in environmental conditions, changes in the engineered cell line) may produce slightly different compounds that act differently within the biologic system or cause peptide denaturation, aggregation, oxidation, or degradation during the manufacturing process.…”

“…These compounds are more difficult to produce, and small changes in the manufacturing process (eg, type of expression system, changes in environmental conditions, changes in the engineered cell line) may produce slightly different compounds that act differently within the biologic system or cause peptide denaturation, aggregation, oxidation, or degradation during the manufacturing process. [8][9][10][11] An interchangeable product is a drug classified as a biosimilar to the reference product and "can be expected to produce the same clinical results as the reference product in any given patient." 2 In the case of Zarxio (filgrastim-sndz), the FDA new releases classify this drug as a biosimilar to Amgen Inc.'s Neupogen (filgrastim), and the FDA approved its use for the same indications as Neupogen.…”