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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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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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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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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...

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.

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Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization

Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization

Published on: January 24, 2025

Not all biologics are equal!

B C Shah¹, M M Tiwari, M R Goede

¹Department of Surgery, University of Nebraska Medical Center, 985126 Nebraska Medical Center, Omaha, NE 68198-5126, USA.

Hernia : the Journal of Hernias and Abdominal Wall Surgery

|December 29, 2010

Summary

This summary is machine-generated.

This study found no ideal biologic for complex ventral hernia repair, with varying rates of recurrence, infection, and explantation among different bioprosthetic materials used in abdominal wall reconstruction.

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Area of Science:

Abdominal wall reconstruction
Bioprosthetic materials in hernia repair
Surgical outcomes research

Background:

Efficacy of biologic meshes for complex ventral hernias is known.
Performance of specific biologic scaffolds regarding recurrence, explantation, and infection is not well-examined.

Purpose of the Study:

Evaluate clinical outcomes of complex ventral hernia repair using bioprosthetic materials.
Compare the performance of different bioprosthetic materials in hernia repair.

Main Methods:

Retrospective analysis of bioprosthetic material use in complex ventral hernia repair.
Study period: January 2002 to February 2009.
Inclusion of 58 patients with complex ventral defects.

Main Results:

High complication rate (72.4%), including surgical wound infections (19.0%), seroma (8.6%), and abscess (5.2%).
One-year hernia recurrence rate was 27.9%; mesh explantation was needed in 17.2%.
AlloDerm showed lower explantation/infection but higher recurrence; cross-linked porcine biologics had higher infection/explantation but lower recurrence; non-cross-linked porcine had lower explantation but higher recurrence and infection.

Conclusions:

Complex ventral hernia repair in contaminated fields is challenging.
Cross-linked porcine biologics had higher infection and explantation rates.
No single bioprosthetic material is ideal; AlloDerm and non-cross-linked porcine showed similar recurrence and explantation rates.