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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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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

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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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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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...
216
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
259
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Clinical Applications of Epidermal Stem Cells01:19

Clinical Applications of Epidermal Stem Cells

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

Małgorzata Mazur1, Karolina Olek-Hrab1, Jacek Karczewski2

  • 1Department of Dermatology and Venereology, Poznan University of Medical Sciences, Poznan, Poland. Head of the Department: Prof. Zygmunt Adamski MD, PhD.

Postepy Dermatologii I Alergologii
|January 14, 2016
PubMed
Summary

Biosimilars offer a cost-effective alternative to biological drugs for inflammatory diseases like psoriasis. Careful evaluation of their immunogenicity is crucial for patient safety and regulatory approval.

Keywords:
biosimilarsimmunogenicitypsoriasis

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Area of Science:

  • Pharmacology and Immunology
  • Dermatology
  • Biotechnology

Background:

  • Biological drugs have transformed inflammatory disease treatment, but high costs drive the need for biosimilars.
  • Tumor necrosis factor alpha (TNF-α) inhibitors are key biologicals of interest for biosimilar development in dermatology.
  • The safety of biologicals, particularly their immunogenicity, is a critical consideration.

Purpose of the Study:

  • To discuss the emergence and importance of biosimilars in treating inflammatory conditions.
  • To highlight the unique challenges and considerations for biosimilars compared to traditional generics.
  • To emphasize the regulatory and safety aspects, especially immunogenicity, of biosimilar medicines.

Main Methods:

  • Review of current literature on biologicals and biosimilars in dermatology.
  • Analysis of the regulatory pathway for biosimilar approval.
  • Discussion of safety profiles, focusing on immunogenicity and potential immune activity.

Main Results:

  • Biosimilars are increasingly important due to the high cost of biological therapies.
  • Biosimilars, unlike synthetic generics, require rigorous assessment due to their biological origin.
  • Immunogenicity is a primary safety concern for biosimilars, necessitating thorough evaluation.

Conclusions:

  • Biosimilars are essential for expanding access to advanced therapies for inflammatory diseases.
  • The development and approval of biosimilars require a distinct regulatory and scientific approach compared to generics.
  • Ongoing pharmacovigilance and regulatory discussions are vital for the safe integration of biosimilars into clinical practice.