Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

353
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...
353
Rheumatic Heart Disease III: Medical Management01:21

Rheumatic Heart Disease III: Medical Management

502
Rheumatic heart disease (RHD) management can be divided into two main strategies: prevention and long-term management.Primary PreventionPrimary prevention focuses on timely diagnosis and management of group A streptococcal pharyngitis to prevent acute rheumatic fever. The most widely used antibiotic for treating this condition is intramuscular benzathine penicillin G.Acute Rheumatic Fever TreatmentThe primary treatment goal for a patient diagnosed with acute rheumatic fever is to suppress the...
502
Inflammatory Bowel Disease IV: Pharmacological Management01:29

Inflammatory Bowel Disease IV: Pharmacological Management

955
Upon diagnosis, managing Inflammatory Bowel Disease (IBD) involves addressing several crucial aspects. The primary goals include resting the bowel, correcting malnutrition, and providing symptomatic relief. Resting the bowel may consist of medications to reduce inflammation and promote healing. Correcting malnutrition is essential, often requiring dietary adjustments and nutritional supplements. Symptomatic relief aims to ease pain, diarrhea, and other discomforts in IBD.
Pharmacologic...
955
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

72
PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
72
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

398
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...
398
Microorganisms in Medicine and Therapeutics01:29

Microorganisms in Medicine and Therapeutics

1.4K
Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
1.4K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Longitudinal peripheral blood multi-omic profiling in seropositive individuals identifies immune endotypes and predictive models for future rheumatoid arthritis conversion.

medRxiv : the preprint server for health sciences·2026
Same author

Sustained improvements in spinal pain, morning stiffness, fatigue, sleep, physical function and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: 2-year results from two phase 3 studies.

RMD open·2025
Same author

Greater HIV Viral Load Suppression in Patients Using an Integrated Health System Specialty Pharmacy.

Journal of pharmacy practice·2025
Same author

A Phase 2 Trial of Hydroxychloroquine in Individuals at Risk for Rheumatoid Arthritis.

Arthritis & rheumatology (Hoboken, N.J.)·2025
Same author

A report of the safety of prophylactic spinal fluid drainage in open and endovascular thoracic and thoracoabdominal aortic aneurysm patients.

Journal of vascular surgery·2025
Same author

A new education agenda based on The International Science and Evidence Based Education Assessment.

NPJ science of learning·2025

Related Experiment Video

Updated: Apr 5, 2026

An Adoptive Transfer Model of Rheumatoid Arthritis in Mice
07:37

An Adoptive Transfer Model of Rheumatoid Arthritis in Mice

Published on: June 6, 2025

1.4K

Biosimilars in rheumatology: current perspectives and lessons learnt.

Thomas Dörner1, Jonathan Kay2

  • 1Department of Medicine, Rheumatology and Clinical Immunology, Charite Universitätsmedizin and DRFZ Berlin, Chariteplatz 01, 10017 Berlin, Germany.

Nature Reviews. Rheumatology
|August 19, 2015
PubMed
Summary

Biosimilars offer a comparable therapeutic option for inflammatory diseases. Key challenges include indication extrapolation and post-marketing pharmacovigilance for these advanced biopharmaceuticals.

More Related Videos

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

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

Published on: May 4, 2017

18.3K
Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
08:36

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3

Published on: April 7, 2023

1.7K

Related Experiment Videos

Last Updated: Apr 5, 2026

An Adoptive Transfer Model of Rheumatoid Arthritis in Mice
07:37

An Adoptive Transfer Model of Rheumatoid Arthritis in Mice

Published on: June 6, 2025

1.4K
In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

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

Published on: May 4, 2017

18.3K
Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
08:36

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3

Published on: April 7, 2023

1.7K

Area of Science:

  • Pharmacology
  • Immunology
  • Rheumatology

Background:

  • Biosimilars are highly similar to reference biopharmaceuticals, offering new treatment options for inflammatory diseases.
  • Distinguishing biosimilars from non-evaluated 'biomimics' is crucial for patient safety and regulatory compliance.
  • CT-P13 (infliximab) was the first biosimilar for inflammatory diseases, though indication extrapolation varied by country.

Purpose of the Study:

  • To review recently approved and developing biosimilars for rheumatic diseases.
  • To address challenges associated with biosimilar use, including indication extrapolation and pharmacovigilance.
  • To compare the efficacy, safety, and immunogenicity of biosimilars with their reference products.

Main Methods:

  • Review of regulatory-approved biosimilars within the last three years.
  • Analysis of clinical data regarding efficacy, safety, and immunogenicity.
  • Discussion of regulatory pathways and pharmacovigilance strategies for biosimilars.

Main Results:

  • Biosimilars demonstrate comparable efficacy and safety to reference products.
  • Immunogenicity data suggest similarity, but potential differences between individual biopharmaceuticals warrant monitoring.
  • Challenges remain regarding the extrapolation of indications and the need for robust pharmacovigilance.

Conclusions:

  • Biosimilars represent a valuable therapeutic advancement for inflammatory and rheumatic diseases.
  • Careful consideration of indication extrapolation and comprehensive pharmacovigilance are essential for safe and effective biosimilar implementation.
  • Continued research and monitoring are necessary to fully understand the long-term impact of biosimilars.