A. From 2000 to 2012, about one-third of MS patients filed for bankruptcy due to prescription drug costs. B. In 2016, MS ranked in the top 5 of all prescription drug spending. C. The average cost per MS prescription is about $50 000. D. Interferon β-1a and glatiramer acetate are tied for highest market share of MS treatment.

A. A biosimilar is defined as a biological product that is “highly similar” to an approved biologic reference product. B. According to the FDA, a biosimilar must have no clinically meaningful differences in terms of safety and effectiveness from the reference product; only minor differences in clinically inactive components are allowed. C. Biosimilars must show pharmacokinetic equivalence and similar toxicology to the reference product in order to receive FDA approval. D. Biosimilars are considered to be interchangeable and thus can be substituted without prescriber approval.

A. Generic and brand GA had equivalent efficacy, safety, and tolerability. B. The safety, efficacy, and tolerability outcomes for both generic and brand GA were within 30% of each other. C. Generic and brand GA had efficacy outcomes within 5% of each other; safety was not assessed. D. Generic GA was not superior to the branded drug; safety and tolerability were equivalent between the 2 drugs.

A. Physician and patient education B. Financial incentives to physicians for prescribing them C. Clearer proprietary naming of biosimilars D. Differentiation of biosimilar and original products in electronic systems to prevent inadvertent substitution and facilitate pharmacovigilance

A. Reassure her that the generic GA is a biosimilar and is just as safe and effective as the brand version and set her up to be automatically switched once it becomes available. B. Advise her to wait for the biosimilars that will become available in the next year or so, because her cost savings will be much greater. C. Explain to her that generic drugs must go through the same clinical trials as branded drugs, so their safety and efficacy are guaranteed. D. Explain to her that in order to be approved, generic GA had to show equivalent efficacy and safety to branded GA and offer to discuss the option of switching her medication with her prescribing physician.