Mind the gap: Unequal access to hyaluronidase in Europe

In recent months, dermatologists, oncologists and aesthetic practitioners in Central Europe have faced the withdrawal of the widely used hyaluronidase preparation Hylase® Dessau from national markets in Germany and Austria. As of July 2025, no official product notification from the manufacturer has been published. However, according to the Regional Association of Statutory Health Insurance Physicians of Saxony (Kassenärztliche Vereinigung Sachsen), the product has been withdrawn from the German market due to supply and distribution issues.1 Hospitals can theoretically import the drug from France, but this is a highly bureaucratic process and not feasible for outpatient practices where filler procedures are performed. This development poses a significant risk to patient safety, particularly in the management of hyaluronic acid filler-related vascular complications, where time-critical enzymatic intervention is required to prevent tissue necrosis or even blindness. However, hyaluronidase has broader medical relevance. Beyond aesthetics, it is employed off-label in the management of hyperosmolar extravasations, as an adjunct to ophthalmic local anaesthesia, and in subcutaneous immunoglobulin therapies using recombinant human hyaluronidase preparations (e.g. rHuPH20). Further indications are use in the management of extravasation of vinca alkaloids and paclitaxel. These diverse applications demonstrate that hyaluronidase is not a niche compound but an essential medication in various medical fields.2-4 The regulatory response to this supply disruption varies widely across Europe. In Italy, clinicians rely on pharmacy-prepared hyaluronidase, whose use is subject to legal restrictions and must be utilized within 6 months of preparation. In France and Spain, by contrast, CE-certified injectable hyaluronidase preparations are available via medical distributors for aesthetic use. In summary, there is currently no hyaluronidase product approved for use as a single-agent medication in all these countries. However, therapies containing recombinant human hyaluronidase such as HyQvia® have European Medicines Agency (EMA) approval for use in immunology.4, 5 This fragmented situation highlights that the bottleneck lies not at the level of the EMA but rather in the absence of a centrally authorized hyaluronidase single-agent product, combined with country-specific regulatory and marketing decisions. The lack of a unified European pathway results in unequal access and leaves patients and physicians vulnerable. An officially authorized hyaluronidase product is essential for clinical practice in terms of product liability, quality management and both legal and professional security for practitioners. Historical experiences further highlight the risk. Gallagher et al. documented a nationwide shortage in the United Kingdom that compromised access to hyaluronidase in plastic surgery settings.6 Furthermore, a significant variability in degradation rates of hyaluronidase products calls for standardized and EMA-approved hyaluronidase to reduce clinical unpredictability and treatment uncertainty.7 Multiple long-term studies confirm that recombinant hyaluronidase products are safe, effective and well tolerated in subcutaneous applications.8-10 These data support broader regulatory approval beyond their current use and suggest that such preparations may be a viable replacement in emergency use situations. We therefore call on the EMA and national regulatory agencies to recognize this as a pan-European issue and to fast-track central authorization for safe, standardized hyaluronidase formulations, including recombinant products. In the meantime, harmonized interim solutions, such as compassionate-use import frameworks, should be enacted to prevent dangerous access gaps and ensure clinical readiness for time-critical complications. None. None declared. Not applicable (no patient data or interventions involved). Not applicable. Data sharing is not applicable to this article as no data sets were generated or analyzed during the current study.