June 10 (Reuters) - Organon said on Wednesday the U.S. Food and Drug Administration has approved the expanded use of its ...

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 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 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 ...

One of the biggest changes to food and drug law changes by the 2010 passage of the Patient Protection and Affordable Care Act (PPACA), better known by most as Obamacare, was its provisions for the ...

The fastest-growing area of healthcare spending is prescription drugs. Leading the way is an expensive class of medicines called biologics, which commonly cost up to $200,000 annually. There are ...

“FDA acceptance of the BLA for AVT16 is another important step in advancing our mission to increase access to biologic ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

Patients with diabetic macular edema can expect similar BCVA improvements and CST reductions using an aflibercept biosimilar compared with conventional aflibercept. An aflibercept biosimilar is ...

Evidence suggests that adoption of oncology biosimilars in Medicare value-based payment models has produced substantial cost ...