A significant number of biologics are expected to lose patent protection, opening up a large business opportunity for ...

As Sandoz looks to address the “biosimilar void” created by the scores of lucrative drugs going off patent in the next decade ...

According to the Association for Accessible Medicine’s 2024 U.S. Generic and Biosimilar Medicines Savings Report, the use of Food and Drug Administration-approved generic and biosimilar medicines ...

Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...

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 ...

Both Alvotech ALVO and Teva Pharmaceuticals TEVA operate in the biosimilar space, but their business models differ significantly. ALVO has built its revenue model around partnerships, relying on ...

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

In 2024, the use of generic and biosimilar medicines saved $467 billion for the United States health-care system and the patients who use it, according to a recent report by the Association for ...