Biosimilars

Question 1

Biosimilar Def

Answer 1

Biological medicine designed to be biologically identical toanother biological medicine (reference medicine) already approved for market. With the intention of placing biosimilar on market when ‘innovator’ patent expires

Question 2

Biologic Agents Inherent Degree of variability

Answer 2

Living organisms of the same species (and thus their products) have natural variability. For biological medicines this variance within a batch is accepted but must adhere to expected (limited) range

Question 3

What is a large degree of variability between batches and initial/biosimilars (unaccepted)

Answer 3

Different amino acid sequence (=different function)

Question 4

What is a small degree of variability between batches and initial/biosimilar

Answer 4

Different glycosylation sites on protein chain

Question 5

Comparability Exercise Outline

Answer 5

Reference biosimilar to ‘reference’ product in terms of characteristic qualities, biological activity, safety and efficacy

Question 6

Extrapolation of biosimilar in vitro results

Answer 6

If reference and drug in development have been evaluated to be biosimilar in vitro, then drug in dev doesn’t need clinical trials. Assumed as safe as reference

Question 7

Biosimilar Benefits

Answer 7

Lower cost biologically identical

Question 8

Biosimilar Disadvantages

Answer 8

Significant investment

Question 9

Specific Features of Biosimilar Medicines

Answer 9

physical, chemical and biological properties similar to reference. No differences in clinical performance (minor variability). Strict standards of quality and efficacy

Question 10

Route To Authorising Biosimilars

Answer 10

Medicines produced using biotechnology for specified treatment (eg cancer), company applies to EMA, data eval by scientific committee, EMA completes scientific review and sent to european commission to be approved for market. Individual countries choose whether it goes to government

Question 11

Comparability Studies

Answer 11

quality studies (in vitro protein structure + biological function), non-clinical (pharmacodynamics/toxicology) and clinical studies (biosimilarities), immunogenecity

Question 12

Irish Medicines Management Program Outline

Answer 12

Promotes, safe, effective, and cost effective prescribing across Ireland