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 ...

Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number of FDA-approved biosimilars to 63. Forty-one of those biosimilars have ...

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 ...

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 ...

Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US. In 2009, Congress created a regulatory pathway for ...

The Development: The Food and Drug Administration ("FDA") issued two draft guidance documents that would largely eliminate clinical efficacy and switching studies and instead rely on the precision of ...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

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 ...

While the FDA is streamlining regulation of copycat versions of the expensive drugs that millions take for arthritis, cancer, and other diseases, the U.S. patent office is making it harder for the ...

Biologic therapies, such as monoclonal antibodies and colony-stimulating factors, have an important role in modern medical practice, but also create challenges due to their relatively high cost. Using ...

Biosimilars are driving down drug costs, expanding access to critical treatments, and creating space for future innovation. In this episode, Linda Choi MacDonald, EVP and Global Head of Commercial at ...