Please provide your email address to receive an email when new articles are posted on . The FDA issued draft guidance that would streamline testing of biosimilars. A separate plan would eliminate ...

Biosimilars have yet to achieve their main purpose: to reduce the costs of complex biological drugs, as generics do for small molecules. Multiple barriers, from development costs to the contracting ...

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

Currently, the global biosimilars market includes monoclonal antibody (mAb) biosimilars, insulins, interferons, erythropoietins, filgrastim, somatropin and follicle-stimulating hormone. Of these, the ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

The U.S. Food and Drug Administration (FDA) significantly revised its approach to biosimilar drug development on October 29. Specifically, FDA issued a draft guidance recommending when comparative ...

A top official from the US Food and Drug Administration (FDA) offered a mixed assessment of the agency’s biosimilars program, noting that although the program is growing, there is more uptake of the ...

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 ...

The collaboration integrates IQVIA’s AI‑enabled clinical trial capabilities to enhance speed and efficiency, per the companies.

HHS Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, MD, and CMS Administrator Mehmet Oz, MD, announced new FDA guidance aimed at making biosimilar drug development faster and less ...

U.S. regulators have proposed loosening some of the clinical trial requirements for companies to win approval for biosimilar versions of insulin products ...