Do not routinely switch from an intravenous formulation of an off-patent biologic drug to a subcutaneous formulation when a biosimilar intravenous formulation is available.

Oct 17, 2018

Do not routinely switch from an intravenous formulation of an off-patent biologic drug to a subcutaneous formulation when a biosimilar intravenous formulation is available.

Type of practice

Drugs

Age

Adult, Geriatric, Pediatric

Topic Area

Clinical Pharmacy and Therapy

Biosimilars are approved by regulatory agencies after demonstrating comparable safety, efficacy, and immunogenicity to the reference (originator) product. They offer benefits such as reducing drug costs, improving treatment access, and fostering innovation. However, competition from biosimilars may be limited by development costs and regulatory barriers, potentially reducing future savings.
By 2032, 110 biologic drugs will lose patent protection worldwide, with a total market value of approximately €30 billion. Among the 26 drugs losing patent protection in the next 10 years, nearly one in three (27%) does not yet have a biosimilar in development, representing a missed opportunity for savings of around €8 billion.
A best-practice example comes from a prospective observational study on rituximab safety in hematology. The high proportion of patients treated with the IV biosimilar showed no scientific or clinical reason to prefer the originator drug or the patented subcutaneous formulation, which may be reserved for selected cases at the physician’s discretion.

Sources

1. European Medicines Agency (EMA). "Biosimilars in the EU - Information guide for healthcare professionals." Disponibile online: https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview.
2. QuintilesIMS. "The Impact of Biosimilar Competition in Europe." Disponibile online: https://www.iqvia.com/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2025. Ultimo accesso 29/01/2026.
3. Generics and Biosimilars Initiative (GaBI). Generics and biosimilars Initiative. Building trust in cost-effective treatments. Disponibile online: https://www.gabionline.net/biosimilars. Ultimo accesso 29/01/2026.
4. “Assessing the Biosimilar Void” IQVIA Institute for Human Data Science. 2023.
5. Urru SAM, Mayer F, Spila Alegiani S et al.The Importance of Real-World Data in Evaluating the Safety of Biosimilars: A Descriptive Study of Clinical Practice in an Oncohematological Italian Population. Cancers (Basel). 2024;16:3419. doi: 10.3390/cancers16193419.

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Attention. Please note that these items are provided only for information and are not intended as a substitute for consultation with a clinician. Patients with any specific questions about the items on this list or their individual situation should consult their clinician.