Add Yahoo as a preferred source to see more of our stories on Google. The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...

With the European Medicines Agency (EMA) adopting a recommendation report to streamline the clinical procedures for ...

This framework is the second that the agency has introduced in recent months to streamline biosimilar development in the ...

Draft recommendations allow skipping at least one U.S.-reference comparative PK study when analytical and other evidence supports biosimilarity, including use of ex-U.S. comparator data in defined ...

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 updated guidance allows originators to cite existing comparative data, not exclusively from the United States, for clinical pharmacokinetic testing. This updated guidance in conjunction with ...

OSUCCC's informatics program automates biosimilar selection, optimizing prior authorization and reducing administrative burdens, increasing biosimilar utilization by 21.9%. The program earned OSUCCC ...

A biosimilar drug manufacturer is concentrating on process optimization to increase uptake of its products in lower-income countries. According to Jeffrey Hausfeld, MD, chairman of the board of ...