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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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...
Hormones of the Pituitary Gland01:27

Hormones of the Pituitary Gland

The small, pea-sized pituitary gland is located at the base of the brain. It is crucial in regulating various bodily functions, from growth to reproduction. The gland is divided into the anterior lobe and the posterior lobe. The secretory cell clusters in the pars distalis of the anterior pituitary lobe are controlled by hypothalamic regulators and synthesize six primary hormones.
The most abundantly secreted hormone from the anterior lobe is the growth hormone, which controls overall growth by...
Hormones and Bone Tissue01:17

Hormones and Bone Tissue

The endocrine system produces and secretes hormones, which interact with the skeletal system. These hormones control bone growth, maintain bone once it is formed, and remodel it.
Hormones That Influence Osteoblasts and/or Maintain the Matrix
Several hormones are necessary for controlling bone growth and maintaining the bone matrix. The pituitary gland secretes growth hormone (GH), which, as its name implies, controls bone growth. This happens in several ways: first, it triggers chondrocyte...
Bioequivalence: Overview01:16

Bioequivalence: Overview

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,...
Hybridoma Technology01:31

Hybridoma Technology

Hybridoma technology is used for the large-scale production of monoclonal antibodies. Monoclonal antibodies bind to only a single antigenic determinant or epitope. Such antibodies are used in research, diagnostics, and disease therapy. The hybridoma technology established in 1975 by Georges Köhler and Cesar Milstein was awarded the Nobel Prize in Medicine in 1984 for revolutionizing research and therapy.
Hybridoma Selection
Commonly used fusion techniques — electroporation, polyethylene glycol...
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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 indication due to...

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Related Experiment Video

Updated: May 27, 2026

Comparative Analysis of Human Growth Hormone in Serum Using SPRi, Nano-SPRi and ELISA Assays
11:17

Comparative Analysis of Human Growth Hormone in Serum Using SPRi, Nano-SPRi and ELISA Assays

Published on: January 7, 2016

Biosimilar growth hormone.

Paul Saenger1

  • 1Department of Pediatrics, Division of Pediatric Endocrinology, Albert Einstein College of Medicine, Bronx, NY, USA. phsaenger@aol.com

Indian Journal of Pediatrics
|November 24, 2011
PubMed
Summary

Biosimilar drugs, including growth hormone, offer a cost-effective alternative to originator biologics. Clinical trials demonstrate their comparable safety and efficacy for pediatric use.

Area of Science:

  • Biopharmaceuticals and biosimilars
  • Pharmacoeconomics
  • Regulatory science

Background:

  • The patent expirations of originator biopharmaceuticals have led to the development of biosimilars, also known as follow-on protein products (FOPPs).
  • Biosimilars offer significant cost savings compared to originator drugs.
  • Regulatory frameworks for biosimilars are more established in Europe than in the United States.

Purpose of the Study:

  • To evaluate the scientific viability and clinical performance of biosimilar drugs, with a specific focus on growth hormone.
  • To compare the efficacy and safety of biosimilar growth hormone with reference products in pediatric indications.

Main Methods:

  • Review of clinical trial data for biosimilar growth hormone, including growth rates and Insulin-like Growth Factor 1 (IGF-1) generation.

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A Tissue Culture Model of Estrogen-producing Primary Bovine Granulosa Cells
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Last Updated: May 27, 2026

Comparative Analysis of Human Growth Hormone in Serum Using SPRi, Nano-SPRi and ELISA Assays
11:17

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Published on: January 7, 2016

A Tissue Culture Model of Estrogen-producing Primary Bovine Granulosa Cells
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A Tissue Culture Model of Estrogen-producing Primary Bovine Granulosa Cells

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  • Analysis of regulatory pathways for biosimilars in the US and Europe.
  • Assessment of potential healthcare cost savings.

    • Main Results:

    • Biosimilar somatropin has received approval in both the US and Europe.
    • Clinical trials spanning up to 7 years for pediatric indications show favorable efficacy and safety profiles for biosimilar growth hormone, comparable to reference products.
    • The Obama Administration is supporting the development of regulatory pathways for biologics and biosimilars in the US.

    Conclusions:

    • The scientific validity of biosimilar drugs, particularly growth hormone, is supported by rigorous clinical evidence.
    • Biosimilar growth hormone demonstrates comparable efficacy and safety to originator products for pediatric use.
    • The widespread adoption of biosimilars is expected to yield substantial healthcare cost savings, given the significant global market for biologics.