Biosimilars

Question 1

What is a biosimilar?

Answer 1

1. similar but not identical in structure to the reference product
2. made with the same type of living sources, same treatment benefit, and potential side effects as the RP

Question 2

What is an extrapolation of indications?

Answer 2

1. used for approval of a biosimilar in one or more additional indications that are shared with the reference product
2. NO trials for indications

Question 3

What is an interchangeable biosimilar?

Answer 3

1. may be substituted for a reference product without consulting a prescriber
2. additional trials needed for approval, not all biosimilars have interchangeable status

Question 4

How do biosimilars obtain interchangeability?

Answer 4

no decrease in effectivness or increase in risk when switching

Question 5

What is an example of interchangeable biosimilars?

Answer 5

ADRILADA adalimumuab-afzb
CYLTEZO adalimumuab-adbm
SIMLANDI adalmumab-ryvk

Question 6

What resources are found in the purple book?

Answer 6

licensed biosimilar and interchangeable products, and their reference products.

Question 7

What applications do new biologics and reference products need to complete?

Answer 7

Biologic License Application 351a

Question 8

What applications do biosimilar products need to complete?

Answer 8

BLA 351 k

Question 9

What is an unbranded biosimilar?

Answer 9

1. removes brand name from packaging
2. no guidance on interchangeability, not in purple book

Question 10

Can a pharmacist substitute a biological product in Pennsylvania?

Answer 10

yes, must communicate substitution to the provider (name and manufacture)

Question 11

What is a pharmacists role in biosimilars?

Answer 11

1. prescriber communications
2. patient communications
3. post marketing surveillance
4. education