As with New Chemical Entities (NCEs) or New Biological Entities (NBEs), the legislative basis for the evaluation and registration of biosimilars is Section 25 of the Therapeutic Goods Act (1989), and with reference to Therapeutic Goods Regulations (1990) Subregulations 16C and 16D. 

Related Therapeutic Goods Orders:

• TGO No. 50 - General Standard for Pyrogen and Endotoxin Content of Therapeutic Goods;
• TGO No. 69 - General requirements for labels for medicines
• TGO No. 77 - Microbiological Standards for Medicines