可互换生物类似品名称的监管要求
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
概括
自2020年以来,美国食品和药物管理局 (FDA) 已经批准了26种可互换的生物类似药,最近的批准加速. 新的FDA指导可能会进一步简化这一过程,潜在地降低成本并增加生物类似药的采用.
科学领域:
- 制药科学 制药科学
- 监管科学 监管科学
- 卫生经济学 卫生经济学
背景情况:
- 美国食品和药物管理局 (FDA) 最初要求进行广泛的III期临床试验,以进行可互换生物类似药的指定.
- 最近的指导草案 (2024年6月) 将重点从临床数据转移到分析数据,可能会改变批准途径.
研究的目的:
- 分析2019年至2025年美国可互换生物类似药批准的趋势.
- 检查可互换生物类似药的制造商战略和监管时间表.
- 评估FDA不断变化的指导方针对生物类似药开发的影响.
主要方法:
- 利用FDA紫色书档案 (截至2025年9月) 来识别可互换的生物类似药和相关数据.
- 分析了按年,制造商,产品类别和提交策略的批准趋势.
- 根据FDA提交和批准日期计算平均监管批准时间表.
主要成果:
- 自2020年以来批准的26种可互换的生物类似药;2024年1月至2025年9月期间批准的19种.
- 阿达利穆马布生物类似药占据了很大一部分 (6项批准).
- 平均批准时间显著减少,从798天 (2020) 减少到364天 (2024).
- 同时提交可互换性成为主要策略.
结论:
- 同时可互换的指定现在是主要的监管途径.
- 美国食品和药物管理局2024年6月的指导草案可能通过删除切换研究要求来降低开发成本和时间表.
- 这些监管转变,加上教育,可以促进生物类似药的吸收,降低生物药物成本.
相关概念视频
01:28Drug Products: Biologics, Biosimilars and Interchangeables
223
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...
223
01:13Bioequivalence studies: Biowaivers
211
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...
211
01:16Bioequivalence: Overview
1.7K
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,...
1.7K
01:26Pharmaceutical Equivalents
171
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.
171
01:09Bioequivalence of Drugs: Drugs with Multiple Indications
144
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...
144
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
141
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,...
141