Forbes contributors publish independent expert analyses and insights. Ge Bai is professor of accounting & health policy at Johns Hopkins. Biologic drugs, made from living organisms and usually taken ...

Add Yahoo as a preferred source to see more of our stories on Google. FDA Commissioner Marty Makary speaks in the Oval Office at the White House on May 05, 2025. (Anna Moneymaker via Getty Images) ...

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 ...

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 ...

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 ...

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 ...

Owen Hosseinzadeh, Maarika Kimbrell, Christina Macdougall, Ph.d. FDA recently issued a new draft guidance titled Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: ...

Within ten years, a patient may find that even a decades-old biologic treatment option they need has no other lower-cost alternative — and the one that’s available is prohibitively expensive and not ...

The Development: The Food and Drug Administration ("FDA") issued two draft guidance documents that would largely eliminate clinical efficacy and switching studies and instead rely on the precision of ...

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 ...

Shares of Alvotech slid after the Food and Drug Administration sent a complete response letter saying the company would have to resolve certain deficiencies before it could receive approval for its ...