FDA continues to indicate that the Company can conduct a comparability study rather than efficacy studies FDA provides clear guidance on approvability expectations for pharmacokinetic (PK) performance ...

Biological products, or biologics, are large, complex molecules produced in living systems such as therapeutic proteins, antibodies, and gene- or cell-based therapies. Under the Public Health Service ...

A new study published in Therapeutic Innovation & Regulatory Science provides crucial insights into the design and ...

FDA open to pooling data from ongoing Phase I/II studies of LX2006 with data from pivotal trial, and to earlier co-primary endpoint assessment, to support a Biologics License Application FDA approved ...

The regulatory landscape for biosimilars is undergoing significant change on both sides of the Atlantic. Recent developments signal a potential shift away from the requirement for a clinical efficacy ...