Pharmaceutical Research (09/17/2015) Declerck, P.; Farouk-Rezk, M.; Rudd, P.M.

Biologic drugs are significantly more complicated than small molecular-weight drugs; but because most of the information on the biotherapeutics manufacturing process is proprietary, the data is not fully accessible by the public. The resulting information gap is "a key challenge for biosimilar developers and plays a key role in explaining the differences in regulatory pathways required to demonstrate biosimilarity versus those required to ensure that a change in manufacturing process did not have implications on safety and efficacy," researchers report. Reasons for manufacturing process changes include response to regulatory requirements, up-scaling production, change in facility, change in raw materials, improving quality control, and optimizing production efficiency. According to the researchers, the extent of the change generally reflects the scale of analysis needed to evaluate the quality. Biosimilar developers begin with some fundamental differences--such as a new cell line and a knowledge gap of the innovator's processes--and they must make sure that any differences from the innovators do not affect their product's safety and efficacy.

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