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

In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The ...

The Food and Drug Administration said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive ...

Please provide your email address to receive an email when new articles are posted on . An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...

The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic drugs made with or isolated from living organisms such as ...

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 ...