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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

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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Bioequivalence studies: Biowaivers01:13

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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...
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Bioequivalence: Overview01:16

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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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Pharmaceutical Equivalents01:26

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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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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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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...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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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,...
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Regulatory Requirements for Interchangeable Biosimilar Designation.

Praveen J Samy1, Morgane C Mouslim2,3, Charles L Bennett4

  • 1Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

Therapeutic Innovation & Regulatory Science
|November 16, 2025
PubMed
Summary
This summary is machine-generated.

The US Food and Drug Administration (FDA) has approved 26 interchangeable biosimilars since 2020, with recent approvals accelerating. New FDA guidance may further streamline the process, potentially reducing costs and increasing biosimilar adoption.

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Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Science
  • Health Economics

Background:

  • The US Food and Drug Administration (FDA) initially required extensive phase III clinical trials for interchangeable biosimilar designation.
  • Recent draft guidance (June 2024) shifts focus from clinical to analytical data, potentially altering approval pathways.

Purpose of the Study:

  • To analyze trends in US interchangeable biosimilar approvals from 2019 to 2025.
  • To examine manufacturer strategies and regulatory timelines for interchangeable biosimilars.
  • To assess the impact of evolving FDA guidance on biosimilar development.

Main Methods:

  • Utilized the FDA Purple Book archive (as of September 2025) to identify interchangeable biosimilars and related data.
  • Analyzed approval trends by year, manufacturer, product class, and submission strategy.
  • Calculated average regulatory approval timelines based on FDA submission and approval dates.

Main Results:

  • 26 interchangeable biosimilars approved since 2020; 19 approved between January 2024 and September 2025.
  • Adalimumab biosimilars represent a significant portion (6 approvals).
  • Average approval timelines decreased significantly, from 798 days (2020) to 364 days (2024).
  • Concurrent submission for interchangeability became the predominant strategy.

Conclusions:

  • Concurrent interchangeable designation is now the primary regulatory pathway.
  • The FDA's June 2024 Draft Guidance may reduce development costs and timelines by removing switching study requirements.
  • These regulatory shifts, coupled with education, could boost biosimilar uptake and lower biologic drug costs.