Biosimilars

Question 1

What is the definition of Biosimilars?

Answer 1

• A version of an already registered biological medicine that:
  
  • Has a demonstrable similarity in physiochemical, biological and immunological characteristics, efficacy and safety

Question 2

Are biosimilars generic biological medicines?

Answer 2

• A biosimilar is not a generic biological medicine
• They’re not composed of a single, pure substance, but are invariably complex, micro-heterogeneous mixtures of isoforms of the desired substance

Question 3

What 2 Specific biosimilar uptake drivers are being implemented?

Answer 3

• Encouraging prescribing of a biosimilar brand rather than the reference biological brand for treatment naïve patients
• Providing for a simpler and faster approval process for prescribing biosimilar brands (e.g. streamlined authority) while maintaining an existing higher level authority requirement for the reference biological brand

Question 4

What kind of molecules are Conventional Drugs?

What is the difference between brand and generic?

Answer 4

• Conventional drugs are small molecules, some exist as high molecular weight polymeric materials
• Completely characterised for purity, impurities, degradation chemistry and stability before marketing
• Delivery system can play a big role in their biological activity
• A generic of the branded drug is exactly similar compund, delivered by same route of administration, and proved to be bioequivalent - the only difference permitted is in excipients and appearance

Question 5

What kind of molecules are biologics?

Answer 5

• Biologics are generally complex large molecules, where activity can be largely influenced by configuration and protein folding
• The production process of these compounds is very complex and influenced by a range of factors affecting fermentation/culture process

Question 6

List Quality Issues of Biosimilarity

Answer 6

• Expression system
• Manufacturing process
• Physiochemical properties
• Functional activities
• Receptor Binding and Immunochemical properties
• Impurities
• Reference Product and Reference Standard
• Finished drug product
• Stability

Question 7

Dosage Form and Indications

The following differences are acceptable?

Answer 7

• Different containers/closure system
• Fewer routes of administration
• Fewer conditions for use
• Non-US licensed reference products (with certain conditions)

Question 8

List the Factors that make Candidates for Biosimilars

Answer 8

• A well-characterised biological product similar to an approved reference product with expired patents and exclusivity
• Structurally highly similar or identical
• Same indications and same MOAs
• Comparability by quality, pre-clinical and clinical testing
• Abbreviated data plus existing data for approval as permitted by law or regulations
• Meeting quality standards including GMP
• Pharmacovigilance program for post-approval monitoring

Question 9

What are the Cost Implications of Generics and Biosimilars?

Answer 9

• For small molecules generics, the price of a generic can be as low as 80% of a branded product, since the products are considered identical
• With biosimilars, average price reduction in Europe is 10-30% of the reference product
  
  • The saving may sound small, but can make a big difference for costly medicines