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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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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

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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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Pharmaceutical Equivalents01:26

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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.
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Bioequivalence studies: Biowaivers01:13

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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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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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Biosimilars in Dermatology: Current Situation (Part II).

L Puig1, G Carretero2, E Daudén3

  • 1Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, España.

Actas Dermo-Sifiliograficas
|June 8, 2015
PubMed
Summary
This summary is machine-generated.

The first infliximab biosimilar for psoriasis is now available in Spain, prompting discussions on economic impacts and prescribing changes. Future biosimilars will also be reviewed for efficacy, safety, and healthcare system sustainability.

Keywords:
AdalimumabBiologicBiológicoBiosimilarClinical trialsEnsayos clínicosEtanerceptInfliximabIntercambiabilidadInterchangeabilityLegislaciónLegislationPsoriasisSubstitutionSustitución

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Area of Science:

  • Dermatology
  • Pharmacoeconomics
  • Biotechnology

Background:

  • The Spanish market has seen the introduction of the first biosimilar infliximab, a biologic agent for psoriasis treatment.
  • The anticipated arrival of more biosimilars will likely influence dermatologists' prescribing habits and the economic landscape of psoriasis care.

Purpose of the Study:

  • To examine the economic repercussions and shifts in dermatological prescribing patterns due to the introduction of biosimilar infliximab.
  • To address contentious issues including indication extrapolation, interchangeability, and automatic substitution for biosimilars.
  • To review current biosimilars in development for psoriasis and evaluate their potential efficacy, safety, and contribution to healthcare sustainability.

Main Methods:

  • Review of market entry data for biosimilar infliximab in Spain.
  • Analysis of current literature and clinical development pipelines for psoriasis biosimilars.
  • Discussion of regulatory and clinical considerations such as indication extrapolation and interchangeability.

Main Results:

  • The first biosimilar infliximab has entered the Spanish market, with further introductions expected.
  • Key issues like extrapolation, interchangeability, and substitution require careful consideration.
  • Several biosimilars are in development, aiming for comparable efficacy and safety to reference products.

Conclusions:

  • The advent of biosimilar infliximab necessitates a re-evaluation of treatment strategies and economic models in psoriasis care.
  • Careful assessment of biosimilar data is crucial for ensuring patient safety and therapeutic equivalence.
  • Biosimilars hold the potential to enhance the sustainability of public healthcare systems by offering cost-effective treatment options.