• Biosimilars cannot be considered generic biologics.
• Biosimilar development and approval is based on the totality of evidence.
  • Designed to demonstrate biosimilar is highly similar to RP
  • Not to independently establish its safety and effectiveness
• Manufacturers use a stepwise approach to demonstrate biosimilarity.
  • Similarity in structure and function
  • Scientific rigor and state-of-art analytics to identify any differences in “Critical Quality Attributes” to ensure desired quality
  • Taking into account safety and efficacy
• Small structural differences are permitted provided no impact biologic function, clinical safety or efficacy.
  • Small structural differences reconciled in studies demonstrating differences are not clinically meaningful
• Because immunogenicity is unpredictable, assessment of a biosimilar must be based on a thorough risk-benefit analysis and robust post-marketing risk management programs such that physicians and pharmacists remain alert to unexplained changes in drug efficacy or side effects.

Download Section 1 (PDF File)

Considerations

• The FDA allows for extrapolation of indication for biosimilars, and available data suggests that biosimilars to anti-TNFs will behave similarly to their reference products.
• No biosimilar in the U.S. yet has interchange-able designation, in patients with IBD.
• Safety remains uncertain with double and triple switches.
• Drug assays for reference products are expected to work similarly for biosimilars.
• Anti-drug antibodies to reference products WILL cross-react to biosimilars (and vice versa).
• Providers can feel as comfortable starting a new patient on a biosimilar as on its reference biologic.

Download Section 2 (PDF File)

• Help patients understand the difference between biologics to biosimilars.
• Help patients feel comfortable using or switching to biosimilars.
• Understand that living with chronic illness is expensive, so cost-savings may matter to many patients.
• Show confidence about treatment choices.
• Remember the nocebo effect (patient doing fine on biologic, so any change is going to be attributed to biosimilar).
• Know patient PK status before making any non-medical changes.
• Lack of data regarding risks of non-medical switching across multiple biosimilars.

Download Section 3 (PDF File)