Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Therapeutic Biologics Applications (BLA)

Biosimilars

                        
                Biosimilar Basics for Patients
          Overview for Health Care Professionals
          Review and Approval
          Biological Product Innovation and Competition
          Biosimilar Product Information
          Biosimilars | Science and Research
          Industry Information and Guidance
          Curriculum Materials for Health Care Degree Programs | Biosimilars
          Multimedia Education Materials | Biosimilars Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Types of Applications
          Therapeutic Biologics Applications (BLA)
          BiosimilarsTherapeutic Biologics Applications (BLA) Biosimilars
  	
        Share
    Post
    Linkedin

    Email
    PrintBiosimilars are safe and effective treatment options for many illnesses such as chronic skin and bowel diseases (like psoriasis, irritable bowel syndrome, Crohn’s disease and colitis), arthritis, kidney conditions, and cancer. Biosimilars increase access to lifesaving medications at potentially lower costs. Explore the website to learn more about biosimilars and to access all FDA’s educational resources for health care providers and patients.
Sub-Topic Paragraphs
          Biosimilar PagesBasics For Patients

                    Basics for Patients
            Find useful information on biologics, including biosimilars
          
          Overview for HCP

                    Overview for Health Care Professionals
            Learn about biologics, including biosimilars and interchangeables
    
          Review and Approval

                    Review and Approval
            Review and approval for biosimilars and interchangeables
    
          Biologic Innovation and Competition

                    Biological Product Innovation and Competition
            Discover how FDA encourages biologic innovation and competition
    
          Industry Resources

                    Industry Resources
            Access industry resources on biologics, including biosimilars
    
          Science and Research

                    Science and Research
            FDA’s scientific research on biosimilars and interchangeables
          Product Information and Education ResourcesProduct Information

                    Product Information
            Information about FDA-approved biosimilar products
          
          Curriculum Materials for Health Care Programs

                    Curriculum Materials for Health Care Programs
            Explore our educational materials on biosimilars
    
          Multimedia Education Materials

                    Multimedia Education Materials
            Explore materials to help promote understanding of biosimilars

                                                                                  Content current as of:
      03/01/2023
                  
                   
Regulated Product(s)
		 DrugsBiosimilars                
                          

                        Basics for Patients
          Overview for Health Care Professionals
          Review and Approval
          Biological Product Innovation and Competition
          Biosimilar Product Information
          Science and Research
          Industry Information and Guidance
          Curriculum Materials for Health Care Degree Programs
          Multimedia Education Materials
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop