FDA

The FDA breakthrough decision removes clinical efficacy studies from the biosimilar pathway in suitable cases, underscoring a smarter, evidence-based regulatory approach.

FDA Grants First Ever Waiver of Clinical Efficacy Studies for Monoclonal Antibody Biosimilar

FDA approves first medication for obstructive sleep apnea: Eli Lilly’s Zepbound GLP-1 agonist

Yesintek, a ustekinumab biosimilar, indicated for the plaque psoriasis treatment has received approval from both the EMA and FDA.

Biocon’s Yesintek receives EMA and FDA approval as the next ustekinumab biosimilar

Immunotherapy IL-15 agonist

First-in-class IL-15 superagonist wins FDA approval

Denosumab biosimilar for osteoporosis treatment.

First denosumab biosimilar approved by FDA