Celltrion’s Omlyclo is interchangeable with Xolair to treat the same conditions: asthma, chronic rhinosinusitis, food allergy ...

The label expansion couls help J&J establish Tremfya as a successor to Stelara, which is now facing a growing biosimilar ...

If left unchecked, the power of PBMs and their complex relationships within the American healthcare system could lead to higher drug costs and diminished returns.

The FDA has approved Celltrion’s OMLYCLO (omalizumab-igec) as the first and only biosimilar designated as interchangeable ...

OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for ...

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

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

“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 ...

Stoboclo, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Osenvelt, a biosimilar to Xgeva, is indicated for preventing skeletal-related events in ...

The biosimilar approval was based on a comprehensive clinical data package, which included a double-blind, randomized, active-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT04757376) that ...

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 ...

The FDA approved denosumab-bmwo for all indications of the reference drugs Prolia and Xgeva. According to a settlement between Amgen and Celltrion, the biosimilars can be launched as early as June 1.