Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of ...

Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...

South Korean biotech firms are targeting the $26 billion biosimilar market opening up as patents expire on more than 10 ...

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

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

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 ...

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

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

“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 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 ...

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