On 14 December 2018, the FDA approved the Herceptin®-biosimilar Herzuma® (trastuzumab-pkrb, Celltrion), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer. Herzuma® was approved as biosimilar, not as an interchangeable product.

Data

The Herzuma® approval was based on comparisons of:

• Extensive structural characterisation;
• Functional product characterisation;
• Animal data;
• Human pharmacokinetics;
• Clinical immunogenicity;
• Other clinical data demonstrating that Herzuma® is biosimilar to United States Herceptin® (Genentech / Roche).

Safety

Common adverse events (AEs) of Herzuma® observed in patients with HER2+ breast cancer include: headache, diarrhoea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Serious expected AEs of Herzuma® include worsening of chemotherapy-induced neutropenia.

Similar to Herceptin®, the Herzuma®-label includes a ‘Boxed Warning’ to alert healthcare professionals and patients about the increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-foetal toxicity.

Full prescribing information Herzuma®