FDA updates advertising rules for biologics and biosimilars in evolving drug market
The US Food and Drug Administration (FDA) has released updated draft guidance on how companies should advertise and label biologic and biosimilar products. These medications, which include vaccines, gene therapies and recombinant proteins, now represent the fastest-growing class of drugs in the country. The revised rules aim to reflect recent industry expansion and help streamline their promotion to healthcare providers and patients.
Biological products cover a wide range of treatments, from vaccines and blood components to advanced therapies like gene editing and tissue engineering. Their rising use has made them a major focus for regulators, with the FDA establishing the Biologics Action Plan in 2018 and later creating a dedicated office to oversee these therapies.
The revised draft guidance is now open for public feedback, with responses typically coming from drugmakers, medical professionals and patient groups. Once finalised, the rules will shape how biologics and biosimilars are promoted in an evolving market. The FDA’s ongoing focus on these therapies highlights their expanding role in modern medicine.
