Employing biosimilars in the treatment of inflammatory health conditions: How to and should I?
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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.
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 inflammatory disease states covered by this activity.
By the end of the session the participant will be able to:
- Describe biosimilar drugs, how they differ from generic drugs, the FDA process for their approval.
- Describe practical considerations the clinician needs when determining whether to consider when deciding whether substituting or allowing the substitution of a biosimilar medication for its reference medication, and apply them to patient case(s).
- Describe how biosimilars for inflammatory health conditions are impacting the treatment landscape with respect to number of treatment options, affordability, and safety considerations.
- Identify the currently available and emerging pharmacotherapeutic treatments for management of inflammatory health conditions and apply them to patient cases using evidence-based medicine.
- Describe strategies for helping patients understand the implications of using biosimilars.