Healthcare authorities face increasing pressure to reduce costs, improve access to advanced therapies, and prepare the system for full EU integration. These factors create a growing space for biosimilars, yet legal and regulatory uncertainties remain significant.
Regulatory Framework: EU Alignment with Local Specifics
Serbia follows a regulatory model that closely mirrors EU rules despite not being a Member State. The Medicines and Medical Devices Agency (ALIMS) evaluates biosimilars using criteria aligned with EMA guidelines. The comparability exercise remains central, covering quality, safety, and efficacy. National authorization is required for all biosimilars, since EU centralized approvals do not apply directly in Serbia. This alignment ensures predictability in scientific assessment. It also means that manufacturers planning to operate across CEE can expect a familiar regulatory structure. The differences arise in administrative timelines, document formatting requirements, and the interaction with other national authorities during pricing and reimbursement procedures.
Pricing and Reimbursement Pressures
Pricing remains one of the most significant barriers to successful biosimilar entry in Serbia. The Ministry of Health applies external reference pricing, while the National Health Insurance Fund (RFZO) expects biosimilars to offer notable cost savings compared to reference biologics. These expectations form part of a broader cost-containment strategy and are periodically tightened. Reimbursement decisions follow a formal procedure that includes a pharmacoeconomic evaluation and documentation on budget impact. Placement on the RFZO reimbursement list is essential for most biologics, given their high cost and hospital-based administration. Serbia’s reference pricing groups create additional pressure by setting reimbursement ceilings across therapeutic classes.
Public Procurement: Tender Risks and Challenges
Most biologics in Serbia are supplied to hospitals through public tenders. Biosimilar uptake therefore depends heavily on how tender specifications are drafted and applied. Procurement authorities often request extensive technical documentation: GMP certificates, batch traceability data, delivery schedules, and stability information. Issues may arise when tender documents indirectly favor incumbent suppliers. Suppliers may challenge such favoring conditions, but deadlines for filing appeals remain short and procedural rules strict. Companies planning to participate in tenders should engage early, monitor tender announcements, and prepare to contest discriminatory clauses when necessary.
Interchangeability: Policy Stability with Limited Uptake
Serbia currently prohibits automatic substitution of biologics at the pharmacy level. Physicians retain full discretion when switching patients from a reference biologic to a biosimilar, or between biosimilars. Hospitals influence switching more strongly than individual prescribers because procurement outcomes effectively determine which products are available. Any future change introducing structured switching protocols or limited substitution rules would materially affect market dynamics. Ongoing discussions about the optimization of biologics spending suggest that policymakers may revisit the framework in the coming years.
Intellectual Property: Patent and SPC Landscape
Biologics in Serbia benefit from patent protection and Supplementary Protection Certificates (SPCs). The SPC regime follows EU-aligned rules and can significantly extend exclusivity beyond the basic patent term. Biosimilar producers must therefore conduct careful freedom-to-operate analyses that consider both SPCs and Serbia’s data exclusivity system. Litigation involving biologics remains modest in volume but is expected to increase as more biosimilars seek entry. Serbian courts recognize preliminary injunctions in patent disputes, though technical evidence and expert opinions are critical. Manufacturers should anticipate that IP litigation can delay market entry, especially in product categories with complex manufacturing processes or multiple secondary patents.
Pharmacovigilance and Compliance Obligations
Post-marketing obligations for biosimilars align with EU standards. Companies must ensure robust pharmacovigilance systems, maintain traceability of all batches, and report adverse reactions to ALIMS. Hospital distribution chains, multiple wholesalers, and periodic shortages create compliance risks that should be addressed through internal quality systems. Regulatory inspections and documentation audits have become more frequent, reflecting Serbia’s progress toward EU acquis alignment.
Conclusion
The combination of EU-aligned scientific standards, strict pricing policies, intense procurement competition, and an increasingly active IP landscape creates a complex environment for manufacturers. Successful market entry requires coordinated regulatory planning, careful tender participation, and continuous monitoring of legislative developments.
By Ivan Todorovic, Partner, PR Legal
This article was originally published in Issue 12.11 of the CEE Legal Matters Magazine. If you would like to receive a hard copy of the magazine, you can subscribe here.
