AbbVie’s Humira was the top-selling drug in the world for many years. Now, its sales are eroding as doctors switch to ...

Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and ...

The US Food and Drug Administration (FDA) has approved the first biosimilar form of omalizumab (Xolair) for the treatment of a range of allergic conditions. Omalizumab-igec (Omlyclo) is designed ...

Amneal announced FDA acceptance of its Biologics License Application (BLA) for two proposed denosumab biosimilars ...

Omlyclo is used for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, ...

Johnson & Johnson’s Stelara, Regeneron’s Eylea and Amgen’s Prolia are just some of the drugs facing off against new ...

With another inflammatory bowel disease (IBD) approval in the bag for Tremfya, Johnson & Johnson continues to make good on ...

“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...

The inquiry is the latest effort by the European Commission and European countries to scrutinize potential antitrust behavior ...

The FDA first approved eculizumab for use in adult patients with generalized myasthenia gravis in 2017, before expanding the ...

STEQEYMA®, one of the first-wave biosimilars to STELARA®, is now available in the U.S. Approved for the same indications as ...