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          Nonproprietary Naming of Biological Products Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Nonproprietary Naming of Biological Products Guidance for Industry
					
		
		January 2017


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2013-D-1543
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


This guidance describes FDA’s current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear anonproprietary name2that includes an FDA-designated suffix. Under this naming convention, the nonproprietary name designated for eachoriginator biological product,related biological product, andbiosimilar productwill be a proper name that is a combination of thecore nameand a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.The suffix format described in this guidance


 
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						All written comments should be identified with this document's docket number: FDA-2013-D-1543.

                                                                                  Content current as of:
      11/18/2019
         
                  
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