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 ...

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

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'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 ...

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

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

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

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 ...

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