Biological products, or biologics, are large, complex molecules produced in living systems such as therapeutic proteins, antibodies, and gene- or cell-based therapies. Under the Public Health Service ...

Biosimilars are often promoted as cost-saving alternatives to their reference medications. Designed to provide comparable therapeutic efficacy at a reduced price, they have the potential to lower ...

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 Biosimilars Council, a division of the Association for Accessible Medicines, has published a new position paper outlining the benefits of updating the existing Food and Drug Administration ...

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 ...

Switching from an originator biologic to a biosimilar can sometimes trigger a nocebo effect, where negative expectations lead to worsened symptoms, reduced treatment efficacy, or perceived adverse ...

It is fair to say (no matter what else can be said) that the current administration is outcome- rather than process-driven. This general inclination is true of the Department of Health and Human ...

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 ...

Biosimilar market shares have risen, notably in oncology, ophthalmology, and pegfilgrastim, with significant FDA approvals enhancing competition. Adalimumab biosimilars struggle due to pharmacy ...