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Bioequivalence: Overview01:16

Bioequivalence: Overview

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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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Epidermal stem cells (EpiSCs) are mainly located at the basal layer of the epidermis. These cells repair minor injuries of the skin and replace dead skin cells. However, EpiSCs’ cannot heal severe wounds such as major burns or those from diabetes or hereditary disorders. In such cases, culturing the epidermal stem cells from the patient is possible and has yielded successful treatment options, such as laboratory-grown skin grafts. These grafts are synthesized using a patient’s own...
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The skin is divided into epidermis, dermis, and hypodermis, the skin's outermost, middle, and inner layers. The human epidermal layer regularly undergoes renewal, where old, dead cells are replaced by new cells. Epidermal stem cells or EpiSCs divide and differentiate to restore the lost cells. For the renewal process, some EpiSCs continuously self-renew. In contrast, few others differentiate into transit-amplifying cells, which later form prickle or spinous cells, followed by granular...
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Skin is the first line of defense and encounters a variety of microbes. Some pathogenic strains are often the cause of a broad range of infections of the skin and other body systems. These conditions can affect people of all ages and may have different causes, including genetic factors, infections, autoimmune reactions, environmental factors, and lifestyle choices.
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Updated: Jun 12, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Biosimilars in Dermatology Review.

John Baker1, Robert Kalb1

  • 1Dermatology Department, University at Buffalo, Buffalo, NY, USA.

Journal of Psoriasis and Psoriatic Arthritis
|September 20, 2024
PubMed
Summary

Biosimilars offer significant savings and increased access to valuable medications. Physician education and prescribing incentives are key to realizing biosimilar benefits in the US, where market share is still developing.

Keywords:
adalimumabbiologicbiosimilardermatologymarket entry

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Area of Science:

  • Dermatology
  • Pharmacoeconomics
  • Drug Development

Background:

  • Biosimilar medications, such as infliximab and rituximab, are FDA-approved and increasing in dermatology.
  • The upcoming availability of adalimumab biosimilars in 2023 signifies growing interest and potential market expansion.
  • Biosimilars aim to enhance patient access to essential biologic therapies.

Purpose of the Study:

  • To review biosimilar basics and their utilization in dermatology across the US, Asia, and Europe.
  • To analyze the economic impact and market penetration of biosimilars in various global regions.
  • To identify factors influencing the successful adoption of biosimilars in clinical practice.

Main Methods:

  • A comprehensive literature review of biosimilar articles from Ovid/Medline (2015-2023) focusing on dermatology.
  • Inclusion of industry reports and blogs to capture insights into the biosimilar market landscape.
  • Analysis of regional experiences, particularly in Europe and the US, regarding biosimilar uptake and savings.

Main Results:

  • Biosimilars have demonstrated substantial cost savings and market share growth, especially in Europe due to longer market experience.
  • The extent of savings and market share varies by country, influenced by prescribing habits and financial incentives.
  • Current biosimilars in the US have not yet achieved the same level of savings and market penetration seen in Europe.

Conclusions:

  • Significant cost savings are achievable with biosimilars, but physician education and prescribing incentives are critical for maximizing these benefits.
  • The future market share of biosimilars in the US remains uncertain and will depend on policy and physician adoption.
  • Optimizing biosimilar utilization requires a multi-faceted approach addressing both healthcare provider education and economic drivers.