Panelists discuss how the Inflation Reduction Act (IRA) of 2022 has influenced biosimilar utilization in the US health care system through its pharmacy provisions targeting Medicare patients, ...

Biosimilars are near-identical versions of biologic cancer drugs, available at lower costs. Germany saves hundreds of millions annually from just one biosimilar drug. Patient mistrust and policy ...

Biologics are complex medications produced through biological processes or from living organisms such as proteins and genes. Biosimilars are what they sound like — similar to, but not the same as, an ...

Forbes contributors publish independent expert analyses and insights. Joshua Cohen is a Boston-based writer who covers health policy. Pharmacy benefit managers take different approaches to controlling ...

The Development: The Food and Drug Administration ("FDA") issued two draft guidance documents that would largely eliminate clinical efficacy and switching studies and instead rely on the precision of ...

The FDA released draft guidance indicating it may approve certain biosimilars without requiring a comparative efficacy study (CES), traditionally a costly and time-intensive step.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

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 ...

Patent litigation reform could accelerate US biosimilar market entry, which lags behind the EU due to protracted legal processes. Biosimilar manufacturers face options like pre-clearance, "at-risk" ...

Biosimilars are gaining traction as competitors aim to capture market share from branded biologics such as Humira and Neulasta. Humira now faces competition from seven biosimilars, while Neulasta has ...

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 agency announced moves to cut regulatory obstacles for the makers of biosimilar drugs, which are akin to generics and may help lower drug costs. By Rebecca Robbins The Food and Drug Administration ...

Fact: branded biologic drugs are consistently among the most expensive in our healthcare system. 1 Compounding this, chronic conditions – often treated with biologics – are becoming increasingly ...