Biologic disease-modifying agents have transformed the treatment and outcomes of patients with various chronic and disabling immune-mediated conditions.
Biosimilars in immune mediated inflammatory diseases
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- Question 1 of 15
1. Question
1. Which of these biological DMARDs is/are an IL-12/23 receptor blocker?
- Question 2 of 15
2. Question
2. Which of these biological DMARDs is/are an IL-6 receptor blocker?
- Question 3 of 15
3. Question
3. Which of these biological DMARDs act(s) against TNF-α?
- Question 4 of 15
4. Question
4. Biosimilars of which anti-TNF-α biologic are available in South Africa?
- Question 5 of 15
5. Question
5. There is no clinically meaningful difference in terms of safety, potency and purity between biosimilars that are highly similar to reference biologics:
- Question 6 of 15
6. Question
6. Which of these criteria are necessary for the development pathway of biosimilars to meet requirements for SAHPRA registration?
- Question 7 of 15
7. Question
7. Which statement is correct? Prior to registering a proposed biosimilar, SAHPRA requires:
- Question 8 of 15
8. Question
8. In South Africa, pharmacy-based switching of RPs to biosimilars or between biosimilars is allowed:
- Question 9 of 15
9. Question
9. Which statement is incorrect? In terms of biosimilars:
- Question 10 of 15
10. Question
10. Systematic review of switching studies revealed no important efficacy or safety signals associated with the biosimilar used relative to the RP in which of these IMIDs?
- Question 11 of 15
11. Question
11. Which biosimilar, available in South Africa, is approved for the treatment of juvenile idiopathic arthritis?
- Question 12 of 15
12. Question
12. Which biosimilar, available in South Africa, is approved for the treatment of hidradenitis suppurativa?
- Question 13 of 15
13. Question
13. Which biosimilar, available in South Africa, is approved for the treatment of uveitis?
- Question 14 of 15
14. Question
14. Which biosimilar, available in South Africa, is approved for the treatment of paediatric Crohn’s disease and paediatric ulcerative colitis?
- Question 15 of 15
15. Question
15. Worldwide, registries provide important real-world evidence related particularly to adverse events, such as increased risk of infections, lymphoproliferative malignancies and cardiovascular disease, related to the use of biologics, both RPs and biosimilars:
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