The agency will no longer require studies comparing copycat biologics to their branded counterparts, which could help ...

The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...

FDA rewrites biosimilar rules to speed development and lower costs for biologic drugs, supporting federal drug price reduction efforts.

By emphasizing analytical studies instead of routine clinical trials, the FDA signals its intent to reduce the cost (often estimated at $100 million to $300 million) and time (typically 6–9 years) ...

The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex ...

On Wednesday, Oct. 29, the Food and Drug Administration (FDA) issued draft guidance proposing to update its biosimilar review framework. Under the ...

This article compares the global pharmacovigilance standards with the practices followed in Saudi Arabia. It highlights similarities, differences, and areas where the Kingdom has made progress or ...

FDA announces major reforms to streamline biosimilar approvals, potentially saving Americans billions on prescription drug costs by removing extra clinical trial requirements.

For Indian pharmaceutical companies that already supply nearly half of all generic medicines sold in the US, the decision ...