Substituting a prescribed biological medicine requires much more than comparing active substance and price. Since section 40c of the German Medicinal Products Directive entered into force, pharmacies must assess the relationship between authorisations, approved indications, route of administration, strength, pack size, dosage form and, where relevant, the specific container or device. Biosimilar dispensing is therefore a quality-critical workflow that must be represented consistently in pharmacy software and the QMS.
What section 40c changes in practice
The German Federal Joint Committee defines the conditions under which a prescribed biological finished medicinal product may be replaced by a lower-cost alternative. Matching the active substance is not sufficient. The product must cover at least one identical indication and the same routes of administration. Where the reported dosage form is the same, the container described in the product information may also be decisive.
Pre-filled pens, syringes and cartridges illustrate why formally similar products can create different care processes. Trigger mechanism, handling and training needs may differ. Pharmaceutical counselling therefore remains a separate safety step.
Ambiguous prescriptions need a defined escalation route
An active-substance prescription, incomplete details or an unclear device should not be handled by improvisation. The pharmacy needs a documented decision path: which data are checked, when a prescriber must be contacted, who may decide and how the rationale is recorded. Regular substitution, a rebate-contract product, documented non-availability and urgent supply each need clear evidence and billing rules.
Five elements of a robust SOP
- Prescription check: capture product, substance, strength, pack size, dosage form and prescription type.
- Substitution check: compare authorisation relationship, indication, route and device.
- Economic selection: apply rebate contracts, price anchors and dispensing priority transparently.
- Counselling: explain device differences and confirm safe use.
- Documentation: record exceptions, non-availability, urgent supply and professional consultation.
tiger.PHARMA position and services
tiger.PHARMA treats biosimilar substitution as an end-to-end process spanning master data, pharmacy systems, professional decisions and reimbursement. For pharmacies we develop risk-based SOPs, checklists, escalation paths and training. For pharmaceutical wholesalers we improve data quality, assortment logic and the reliable provision of substitution-relevant information. For manufacturers and logistics partners we connect product, pack and device data with controlled change management.
The aim is not additional paperwork but an executable daily process with clear ownership. This reduces dispensing errors, avoidable queries and retaxation risk while preserving individual patient counselling.