Biosimilar approvals in Turkey require comparability studies and TİTCK marketing authorization.
Regulatory Framework
Medicinal Products Regulation, TİTCK guidelines and TRIPS compliance.
Investment Vehicle & Market Entry
Pharma JSC with GMP-certified facility; CMO partnerships available.
Incentives & Tax Treatment
Local production incentives, public procurement preference and R&D credits.
Licensing & Compliance
TİTCK manufacturing license, GMP certificate and marketing authorization.
IP & Data Protection
6-year data exclusivity; patent linkage via Civil Code injunction.
Dispute Resolution
Administrative courts for TİTCK decisions; IP courts for patent infringement.
How Alyar Helps
Alyar Hukuk Danışmanlık provides end-to-end legal support including regulatory diligence, structuring, licensing, dispute resolution and ongoing compliance for international clients.