The Trump administration is moving to speed up approvals of copycat biologic drugs as a way to lower health costs and boost ...

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

March 9 (Reuters) - The U.S. health regulator issued a draft guidance on Monday to help drugmakers develop cheaper versions ...

Sandoz has not minced words about the massive, yet largely untapped opportunity biosimilar makers are presented with as dozens of branded medicines inch toward the patent cliff in the next decade.& | ...

The Association for Accessible Medicines and its Biosimilars Council have released an analysis undertaken by the IQVIA Institute for Human Data Science on behalf of AAM assessing the impact of patent ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

The Inflation Reduction Act (IRA) has reshaped how Medicare covers and reimburses prescription drugs. For the first time, the federal ...

The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, ...

The FDA has decided that biosimilar medications must have unique naming features, distinguishing them from brand-name biologics in a move to improve patient safety, according to a STAT news report. 1.

The FDA released draft guidance indicating it may approve certain biosimilars without requiring a comparative efficacy study (CES), traditionally a costly and time-intensive step. Instead, advances in ...

Sandoz announced the creation of a new biosimilar development, manufacturing and supply unit that will be headed by industry veteran Armin Metzger, who will join Sandoz on April 1.

With the first biosimilar approved by the US Food and Drug Administration (FDA) in March and a second approval likely in the next few months, practical and operational challenges are already starting, ...