Incorporating biosimilars into practice to treat immunologic disease states: Benefits, concerns, and the present treatment landscape
Activity Description / Statement of Need:
In this online, self-learning activity:
Biosimilar drugs are products meant to be similar in quality, safety, and efficacy to an already licensed reference biotherapeutic product. Whereas generics are virtually identical replicas of conventional medications, biosimilars are not the same as the original product – a practically unavoidable outcome because of the considerably large molecular structure that biologics mimic. The literature suggests that learning activities focused on the evolving landscape of biosimilars, which are germane to the therapeutic area because of their potential role in cost containment. Both the FDA and medical literature independently affirm the need for clinician education on biosimilars, including: comparative efficacy; adverse event rates and management (potential concerns have included immunogenicity); regulatory guidance on interchangeability and substitution – including prescribers retaining some degree of ability to intervene in a product’s substitution at the dispensing stage; and cost considerations. There has been significant progress in the adoption of biosimilars since the first one received FDA approval over half a decade ago. Clinicians who employ biosimilars have a generally positive view of them. However, challenges remain.
Target Audience:
The following healthcare professionals: rheumatologists, gastroenterologists, and primary care physicians; physician assistants, nurse practitioners, and pharmacists who practice in the aforementioned areas of specialty; and any other healthcare professionals with an interest in or who clinically encounter patients with the immune-mediated and autoimmune disease states covered by this activity.
Details
Activity Description / Statement of Need:
In this online, self-learning activity:
Biosimilar drugs are products meant to be similar in quality, safety, and efficacy to an already licensed reference biotherapeutic product. Whereas generics are virtually identical replicas of conventional medications, biosimilars are not the same as the original product – a practically unavoidable outcome because of the considerably large molecular structure that biologics mimic. The literature suggests that learning activities focused on the evolving landscape of biosimilars, which are germane to the therapeutic area because of their potential role in cost containment. Both the FDA and medical literature independently affirm the need for clinician education on biosimilars, including: comparative efficacy; adverse event rates and management (potential concerns have included immunogenicity); regulatory guidance on interchangeability and substitution – including prescribers retaining some degree of ability to intervene in a product’s substitution at the dispensing stage; and cost considerations. There has been significant progress in the adoption of biosimilars since the first one received FDA approval over half a decade ago. Clinicians who employ biosimilars have a generally positive view of them. However, challenges remain.
Target Audience:
The following healthcare professionals: rheumatologists, gastroenterologists, and primary care physicians; physician assistants, nurse practitioners, and pharmacists who practice in the aforementioned areas of specialty; and any other healthcare professionals with an interest in or who clinically encounter patients with the immune-mediated and autoimmune disease states covered by this activity.