Biosimilars

What are biosimilars? The Pharmacy Times® Biosimilars resource center keeps those in the space up to date with the latest clinical news and articles, coverage from conferences and meetings, links to condition-specific resources, and videos and other content.
 

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The panel explores the appropriateness of switching from a biologic to a biosimilar through consideration of factors such as the curative vs noncurative setting, the EMR system, and patient education.
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The FDA does not usually require animalstudies for biosimilars; therefore, the process can move directly to pharmacokinetic and pharmacodynamic studies.
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Considerations for certain patient factors when recommending a biosimilar over a biologic to treat a patient.
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Marc Earl, PharmD, BCOP, and Tim Peterson, PharmD, BCOP, share their clinical experience with P&T committee decisions, the cost of switching, and the payor selection process for a patient.
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How biologics have changed clinical practice over conventional chemotherapies and currently available biosimilars in the US.
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Defining what it means to have an “interchangeability” designation as it relates to biosimilars and insight on challenges with regulations of holding this status.
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A review of the steps of the FDA approval process for biosimilars and a discussion on immunogenicity and quality assurance for biosimilars.
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Clinical pharmacists provide an overview of the similarities and differences of biosimilars vs biologics including a comparison of dosing and storage conditions.
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A session on the use of biosimilars, a topic that many pharmacists identify to be of growing importance in their practices, concluded the 2019 Directions in Oncology Pharmacy conference.
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Pfizer will become the first to launch 3 oncology monoclonal antibody biosimilar treatments to the US market.
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Biosimilars, which at the most simplistic level can be thought of as a type of generic option for a biologic, offer an opportunity to help reduce total biologic drug spend.
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Trastuzumab-dkst (Ogivri, Mylan, Biocon), a biosimilar to trastuzumab (Herceptin, Genentech Inc.), has been launched in the US, according to an announcement from Mylan N.V. and Biocon Ltd. It is the first biosimilar approved by the FDA and recommended by the FDA Oncologic Drugs Advisory Committee.