Biosimilars in the treatment of malignancies and supportive care

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.

Given the rapid expansion of these product types and the presence of gaps in the area of hematologic malignancies and oncologic and supportive care therapies, this activity has been designed to bring HCPs’ knowledge of biosimilar products in those areas up to date and to improve their competence and performance in employing them in practice.

Target Audience:

The following healthcare professionals: Hematologist-oncologists and medical oncologists; physician assistants, nurse practitioners, and pharmacists who practice in oncology; and any other healthcare professionals with an interest in or who clinically encounter patients with hematologic malignancy or oncologic disease states who may receive treatment with biosimilars.

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.

Given the rapid expansion of these product types and the presence of gaps in the area of hematologic malignancies and oncologic and supportive care therapies, this activity has been designed to bring HCPs’ knowledge of biosimilar products in those areas up to date and to improve their competence and performance in employing them in practice.

Target Audience:

The following healthcare professionals: Hematologist-oncologists and medical oncologists; physician assistants, nurse practitioners, and pharmacists who practice in oncology; and any other healthcare professionals with an interest in or who clinically encounter patients with hematologic malignancy or oncologic disease states who may receive treatment with biosimilars.

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