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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

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Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Bioequivalence: Overview01:16

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Red blood cells  (RBCs) transport oxygen to all body tissues. These cells survive only for 120 days and then need to be replenished. Erythropoiesis is the process of RBC production. In healthy individuals, erythropoiesis ensures all tissues are amply supplied with oxygen. In addition, blood loss due to injury leads to a drop in the physiological oxygen level that will cause erythropoiesis. Any defect in erythropoiesis leads to several physiological disorders, including thalassemia, anemia,...
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The cardiovascular system regulates the number of erythrocytes in the bloodstream to ensure optimal oxygen transport. It also prevents over-proliferation of these cells, which helps to maintain blood viscosity and flow rate.
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EPO then...
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

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The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
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Biosimilar ESAs: a comparative review.

Paul Wilson1, Cheryl Wood

  • 1Darent Valley Hospital, Darenth Wood Road, Dartford, Kent, UK.

Journal of Renal Care
|October 29, 2014
PubMed
Summary
This summary is machine-generated.

Biosimilar erythropoiesis-stimulating agents (ESAs), like epoetin zeta, offer comparable safety and efficacy to reference products. Renal nurses play a key role in educating patients and making informed decisions about these cost-saving biological medicines.

Keywords:
AnaemiaBiosimilarChronic kidney diseaseEpoetin

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Area of Science:

  • Nephrology
  • Pharmacology
  • Nursing

Background:

  • Erythropoiesis-stimulating agents (ESAs) have revolutionized anemia management in chronic kidney disease (CKD).
  • Following patent expiry of originator epoetin alfa, multiple biosimilar ESAs are now available in the nephrology setting.
  • Biosimilars undergo rigorous regulatory approval, demonstrating comparable safety, efficacy, and quality to reference products.

Purpose of the Study:

  • To inform nurses about biosimilar ESAs, emphasizing their differences from reference products and regulatory approval processes.
  • To highlight practical considerations for nurses regarding the use of biosimilar ESAs in CKD patient care.
  • To empower nurses to make informed decisions about incorporating biosimilar ESAs into patient treatment plans.

Main Methods:

  • This review utilizes epoetin zeta as a case study.
  • It examines practical aspects of employing biosimilar ESAs in managing kidney disease patients.
  • The focus is on providing actionable insights for nursing practice.

Main Results:

  • Biosimilar ESAs, exemplified by epoetin zeta, present potential advantages for patients, nurses, and physicians.
  • These advantages include enhanced flexibility in dosage and administration routes.
  • Biosimilars can improve access to biological medicines through cost efficiencies.

Conclusions:

  • Renal nurses are crucial in managing CKD and anemia, encompassing both medication administration and patient education.
  • This review provides practical insights into biosimilar medicine use, aiding nurses in informed decision-making.
  • Understanding biosimilar ESAs supports optimal patient care and treatment adherence in nephrology.