Lecture 14 - Biotechnology and Generics

Question 1

What are Generic Drugs?

Answer 1

They are copies of innovator drugs, providing evidence of safety by demonstrating chemical comparability to innovator drug in the laboratory and efficacy by demonstrating bioequivalence to innovator drug in a clinical trial

Question 2

Why are Generic Drugs cheaper than innovator drugs?

Answer 2

1. No preclinical studies required
   i. Depend on comparability to innovator for animal studies to demonstrate safety
   2. No extensive clinical trials required
   i. To prove comparability to the innovator need a single relatively small bioequivalence clinical study
   ii. Depend on comparability to the innovator to access multiple large scale clinical trials to prove safety and efficacy

Question 3

What is the Basic Generics Strategy?

Answer 3

Loss of Innovator IP > Generic Business > Money
• Expiry/ invalidation/ circumvention of innovator IP is central to a generic business
The value of a company is determined by the value of its ability to gain earliest market entry for a pipeline of drugs

Question 4

What are characteristics of Generics?

Answer 4

• Make copies of medicines
		○ Select targets based on market size
	• Target entry for IP expiry
	• Circumvent or invalidate patents
		○ Target 'evergreening' strategies
	• Launch and market generic medicines at IP expiry
	• No monopoly, large number of competitors - compete on cost
	• Smaller profit margin
	• Useful market life often 3-4 years
	• Pipeline needs to be replenished regularly
	• Consumer benefit
		○ Affordable medicines available

Question 5

What are Simple Generic?

Answer 5

• A drug product that is comparable to brand/ reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use
○ Same API (active pharmaceutical ingredient)

	○ Same route of administration 
	○ Same dosage form
		§ Oral - tablet or capsule not interchangeable
		§ Parenteral - solution and freeze dried not interchangeable 
	○ Same strength
	○ Same conditions of use (eg. Administer with food) 
	○ Inactive ingredients approved for a similar drug 
	○ Same drug blood profile as innovator (eg. Is bioequivalent)

Question 6

What is the development process of a Generic Drug?

Answer 6

Characterization of Reference Product > Design of the Generic Product and Process > Pivotal Biobatch > Bioequivalence Study > Generic Data Pack Review and Registration > Commercial Product Manufacture

Question 7

What are the differences of complex Generic Drugs with Simple Generics?

Answer 7

• Incomplete physio-chemical comparability
○ Different dosage form
○ Novel inactive ingredient
○ Different strength
• Different administration route
• Different usage
• Improved bioavailability or site and duration of action (“supergeneric”)
• Require more data than simple generics to support the safety and efficacy of the drug
○ Often animal studies and human clinical safety/ efficacy
• Increased, separate regulatory requirements “paper New Drug Application (NDA)”
• May not be clinically interchangeable with innovator drug

Question 8

What are Biosimilars?

Answer 8

• Biosimilars are comparable to, not necessarily substitutable for innovator

They have more extensive phyisco-chemical comparability evidence than generics

* Biosimilars much more expensive development pathway than generics 
* Generics can be substituted by clinician or pharmacist for innovator
* Clinician needs evidence to substitute a Biosimilar for innovator 
* Generics can be marketed to wholesalers (compete on price). Biosimilars need marketing to clinicians (compete on price and effectiveness)