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The US Food and Drug Administration (FDA) on Monday finalized guidance to help sponsors of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing applications.

With the patent protection for a number of leading biologic drugs set to expire in the coming years, the race is on within the life sciences industry to develop lower cost alternatives, known as biosimilars. Biologic medicines have revolutionised the treatment of many serious and chronic illnesses in the NHS, ranging from cancer through to rheumatoid arthritis and inflammatory bowel disease. Yet they are costly to develop and manufacture, which means they are expensive for the NHS to prescribe to patients.

EMA is planning to reduce the data requirements for developers of recombinant granulocyte colony stimulating factor (rG-CSF) biosimilars. The proposed changes echo broader shifts in EMA’s approach to biosimilars by reducing the need to run animal tests and clinical trials.