RegulatoryOfficial

Denmark flags supply problems for Biocon's Ogivri 150 mg trastuzumab biosimilar until end-November

🇩🇰 DKMA · Fri 13 Nov 2026

The Danish Medicines Agency reports delivery difficulties affecting Ogivri 150 mg powder for infusion concentrate from Biocon Biologics Finland OY, expected to last from late June to late November 2026.

The Danish Medicines Agency (DKMA) has published a supply notice for Ogivri 150 mg powder for concentrate for solution for infusion, a trastuzumab biosimilar marketed by Biocon Biologics Finland OY. The agency says there are current problems with supply of the product.

According to the notice, the expected duration runs from the end of June to the end of November 2026. The stated cause is delivery difficulties. The notice was first posted on 2 July 2026 and updated on 13 November 2026.

The product's active substance is trastuzumab, with ATC code L01FD01. The notice gives no further detail on the nature of the delivery problem, on which strengths or pack sizes are affected beyond the 150 mg presentation, or on any alternative supply arrangements.

DKMA directs questions about the current status to the company. The notice sits within the agency's section for announcements on medicine supply, which belongs to its wider work on medicine shortages.

What it means for your team

  • Hospital pharmacies and oncology teams in Denmark should check current stock and availability directly with Biocon Biologics Finland OY, as DKMA refers status queries to the company.
  • The expected disruption window ends in late November 2026; the 13 November update does not say whether supply has resumed or the period has been extended.
  • Shortage-management teams may wish to review contingency plans for trastuzumab, since the notice does not describe alternatives or mitigation measures.

Official source: DKMA ↗

Article written by VigiEye from the official source (DKMA). AI-assisted; check the source before acting.

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