FDA approves first Stelara biosimilar, Wezlana

FDA approves first Stelara biosimilar, Wezlana

Stelara is an interleukin-12 and interleukin-23 antagonist used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The original product is available in intravenous and subcutaneous formulations. The FDA has approved Wezlana (ustekinumab-auub), making it the first approval for blockbuster biosimilar drug Stelara (ustekinumab). The agency also granted Wezlana an interchangeability …

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Review: Similar safety profiles of the reference pegfilgrastim biosimilar in clinical studies

Review: Similar safety profiles of the reference pegfilgrastim biosimilar in clinical studies

Filgrastim and pegfilgrastim are recombinant human granulocyte colony-stimulating factor (G-CSF) analogs used to prevent cancer patients from developing febrile neutropenia following chemotherapy. Pegfilgrastim biosimilars currently approved or filed for approval in the United States have demonstrated a high degree of similarity and comparability to the reference product, with no unexpected safety findings, concluded the authors …

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