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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

311
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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Bioequivalence: Overview01:16

Bioequivalence: Overview

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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

Bioequivalence of Drugs: Drugs with Multiple Indications

197
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...
197
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

230
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.
230
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

332
Body: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...
332
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

232
Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
232

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Related Experiment Video

Updated: Feb 26, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Update on Biosimilars in Asia.

Wen-Chan Tsai1

  • 1School of Medicine Kaohsiung Medical University, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou 1st Road, Kaohsiung, Taiwan. d10153@ms14.hinet.net.

Current Rheumatology Reports
|July 19, 2017
PubMed
Summary

Biosimilars offer affordable biologic treatments for Asian patients, driving significant market growth. Continued development requires enhanced manufacturing quality and pharmacovigilance in the region.

Area of Science:

  • Biopharmaceutical development
  • Regulatory science
  • Health economics in Asia

Background:

  • Biologics have transformed disease treatment but remain costly for many Asian patients and governments.
  • High biologic costs create significant financial burdens, limiting access to advanced therapies.
  • Biosimilars present a viable solution to improve affordability and accessibility of biologic treatments.

Purpose of the Study:

  • To provide an updated overview of biosimilar evolution in Asian countries.
  • To examine the manufacturing landscape and regulatory frameworks for biosimilars in Asia.
  • To assess the current status and future directions of biosimilar development across the Asian region.

Main Methods:

  • Review of current literature on biosimilar development and regulation in Asia.
Keywords:
AsiaBiologicsBiosimilars

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  • Analysis of market trends and manufacturing capabilities of biopharmaceutical companies in the region.
  • Examination of evolving regulatory guidelines and pharmacovigilance practices.

    • Main Results:

    • Asia is experiencing a significant boom in biosimilar development and manufacturing.
    • Numerous biopharmaceutical companies are establishing facilities to produce affordable biosimilars.
    • Regulatory guidelines are evolving, with ongoing efforts toward international harmonization.
    • Despite rapid progress, there is a recognized need for improved manufacturing quality and post-market surveillance.

    Conclusions:

    • Biosimilars are crucial for addressing the affordability gap in biologic therapies in Asia.
    • The Asian biosimilar market is rapidly expanding, supported by increasing manufacturing capacity.
    • Further enhancements in quality control and pharmacovigilance are essential for sustained biosimilar success in Asia.