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Drug Products: Biologics, Biosimilars and Interchangeables

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Body: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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Dipeptidyl peptidase 4 (DPP-4) is a serine protease widely distributed in the body. It's involved in the inactivation of GLP-1 and GIP hormones, which are crucial for insulin regulation. DPP-4 inhibitors, such as sitagliptin (Januvia), saxagliptin (Onglyza), linagliptin (Tradjenta), alogliptin (Nesina), and vildagliptin (Galvus), help increase the proportion of active GLP-1, enhancing insulin secretion. These inhibitors work by competitively binding to DPP-4. This binding causes a...
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Amides to Amines: LiAlH4 Reduction01:20

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Amide reduction with strong reducing agents like lithium aluminum hydride proceeds through a nucleophilic acyl substitution to form amines. Primary, secondary, and tertiary amides yield primary, secondary, and tertiary amines, respectively.
Amide reduction requires two equivalents of the reducing agent, acting as a source of hydride ions. As shown in the figure, the reaction is initiated with a nucleophilic attack by the hydride ion at the carbonyl carbon to form a tetrahedral intermediate.
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Piaget's Stage 4 of Cognitive Development01:19

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The formal operational stage, as described in Piaget's cognitive development theory, begins around age 11 and extends into adulthood. It marks the emergence of advanced cognitive abilities that differentiate adolescent and adult thinking from those of younger children. This stage is characterized by abstract reasoning, hypothetical-deductive reasoning, and a more complex understanding of self and others.
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Nitriles to Amines: LiAlH4 Reduction00:55

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Nitriles are reduced to amines in the presence of strong reducing agents like lithium aluminum hydride through a typical nucleophilic acyl substitution. The reaction requires two equivalents of the reducing agent. The reducing agent acts as a source of hydride ions.
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Acid halides are reduced to alcohols in the presence of a strong reducing agent like lithium aluminum hydride.
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Etanercept biosimilar SB-4.

Eleftherios Pelechas1, Alexandros A Drosos1

  • 1a Rheumatology Clinic, Department of Internal Medicine, Medical School , University of Ioannina , Ioannina , Greece.

Expert Opinion on Biological Therapy
|January 9, 2019
PubMed
Summary

SB-4 is a highly similar biosimilar to etanercept (ETN), demonstrating equivalent safety and efficacy for rheumatoid arthritis treatment. It shows promising results, including lower immunogenicity, and is approved in multiple regions.

Keywords:
SB-4biologicsbiosimilaretanerceptmonoclonal antibody

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Area of Science:

  • Rheumatology
  • Immunology
  • Pharmacology

Background:

  • Etanercept (ETN) was the first anti-tumor necrosis factor inhibitor (TNFi) approved for rheumatoid arthritis (RA).
  • Twenty years post-ETN approval, biosimilar development has advanced significantly.
  • SB-4 emerged as a biosimilar candidate for ETN.

Purpose of the Study:

  • To review SB-4 as a biosimilar candidate to ETN.
  • To assess available data on SB-4's safety, efficacy, tolerability, and immunogenicity.
  • To compare SB-4 with its originator, ETN.

Main Methods:

  • Review of existing data on SB-4.
  • Comparison of SB-4 with originator etanercept (ETN).
  • Assessment of pharmacodynamic and pharmacokinetic activities.

Main Results:

  • SB-4 demonstrates high similarity to ETN in safety, efficacy, and tolerability.
  • SB-4 has received approval in Europe, South Korea, Australia, and Canada.
  • SB-4 exhibited lower immunogenicity compared to ETN.
  • Pharmacodynamic and pharmacokinetic activities are equivalent between SB-4 and ETN.

Conclusions:

  • SB-4 is a highly similar and safe alternative to ETN for RA treatment.
  • SB-4 is expected to have comparable efficacy and safety across all approved indications.
  • The data supports SB-4 as a valuable therapeutic option for RA patients.