February 18, 2026
Source: drugdu
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Drugdu.com expert's response:
The consistency between generic drugs and originator drugs is a crucial issue in the pharmaceutical field, with its core lying in assessing whether generic drugs achieve equivalent levels in terms of quality, efficacy, and safety compared to originator drugs. This issue not only concerns patients' rights to medication but also affects the balance between innovation and accessibility in the pharmaceutical industry. The following analysis unfolds from four dimensions: science, policy, economy, and society.
I. Scientific Foundation: Technical Standards for Consistency Evaluation
Pharmaceutical Equivalence:Generic drugs must be identical to originator drugs in terms of active ingredients, dosage forms, strengths, and routes of administration, and demonstrate consistency in physical and chemical properties through tests such as dissolution rate and content uniformity. This serves as the fundamental threshold for generic drug development.
Bioequivalence (BE):It is necessary to prove through human clinical trials or alternative methods (e.g., in vitro models) that the differences in absorption rate and extent between generic and originator drugs do not exceed specified limits (typically 80%-125%). This is the key indicator for evaluating therapeutic consistency.
Clinical Equivalence:In special cases (e.g., drugs with a narrow therapeutic index), large-scale clinical trials are required to further verify differences in real-world efficacy and safety between generic and originator drugs. However, in most cases, bioequivalence can infer clinical equivalence.
Challenges:
The bioequivalence evaluation of complex formulations (e.g., sustained-release, liposomal) is highly challenging.
The formulations and processes of originator drugs are confidential, requiring generic drug companies to reverse-engineer them, which may pose technological barriers.
The correlation between in vitro dissolution profiles and in vivo absorption needs further optimization.
II. Policy Regulation: Global Practices in Consistency Evaluation
International Experience
U.S. FDA: Established a generic drug approval pathway through the Hatch-Waxman Act, requiring generic drugs to be "therapeutically equivalent" to originator drugs, and published the Orange Book as a reference.
EU EMA: Implemented a centralized approval procedure, demanding that generic drugs be "highly similar" to originator drugs in quality, efficacy, and safety, and facilitated cross-border circulation through Mutual Recognition Agreements (MRPs).
Japan PMDA: Launched the "Quality Re-evaluation Project" to systematically assess already-marketed generic drugs, ensuring consistency with originator drugs in quality.
China's Progress
Initiated consistency evaluation for generic drugs in 2016, requiring those approved before the implementation of the new chemical drug registration classification to pass bioequivalence trials or clinical validation.
Promoted consistency evaluation for essential medicines through policies such as the "289 Essential Medicines List" to enhance the quality of medications at the grassroots level.
Joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to align regulatory standards with international practices.
Policy Implications:
Eliminate low-quality generic drugs and optimize the industrial structure.
Reduce healthcare expenditures and improve drug accessibility.
Drive enterprises to transition from "low-level repetition" to "high-quality innovation."
III. Economic Impact: Balancing Innovation and Accessibility
Cost Advantages:Generic drugs typically cost 10%-30% of originator drugs, significantly reducing patient burdens and healthcare expenditures. For example, India has become the "pharmacy of the world" through generic drug exports, providing low-cost medications to developing countries globally.
Market Incentives
Patent Cliff: The expiration of originator drug patents leads to a sharp decline in their sales upon generic drug entry (e.g., Lipitor, Plavix), compelling originator companies to accelerate innovation.
First-Generic Incentives: Some countries (e.g., the U.S.) grant a 180-day market exclusivity period to the first generic drug approver, encouraging companies to challenge patents.
Industrial Upgrading
Consistency evaluation compels enterprises to enhance their R&D and production capabilities, driving China's transition from a major generic drug producer to a powerful one. For instance, companies like Huahai Pharmaceutical and Qilu Pharmaceutical have obtained international certifications and entered European and U.S. markets.
Controversies:
Over-reliance on generic drugs may weaken enterprises' innovation incentives.
Low-price competition risks "driving out good drugs with inferior ones."
IV. Social Value: Patient Rights and Public Health
Medication Safety
Consistency evaluation reduces risks of suboptimal efficacy or adverse reactions due to quality disparities. For example, China previously experienced public safety crises like the "Qiqihar No.2 Pharmaceutical Factory incident" due to inconsistent generic drug quality.
Healthcare Equity
The widespread availability of high-quality generic drugs enables more patients to access treatment, particularly those with chronic diseases (e.g., hypertension, diabetes) and cancer.
Global Health
Generic drugs play a pivotal role in treating infectious diseases like AIDS and malaria. For instance, Indian generic drug companies, through compulsory licensing, produced anti-AIDS drugs, reducing treatment costs for African patients by over 90%.
V. Future Challenges and Directions
Complex Formulations and Biosimilars
More precise evaluation methods (e.g., physiologically based pharmacokinetic models) are needed to address novel drugs like nanomedicines and biosimilars.
Real-World Data (RWD) Application
Leverage electronic health records, healthcare insurance databases, and other real-world data to supplement traditional clinical trials and accelerate generic drug approvals.
International Mutual Recognition and Collaboration
Promote the internationalization of regulatory standards, reduce redundant evaluations, and facilitate global generic drug circulation.
Conclusion
The consistency between generic and originator drugs represents an inevitable path for the development of the pharmaceutical industry, aiming to achieve a virtuous cycle of "quality first, innovation-driven, and patient-benefiting" through scientific evaluation and policy guidance. For individuals, consistency evaluation safeguards medication safety and accessibility; for the industry, it drives transformation and upgrading; for society, it promotes healthcare equity and global health. Moving forward, it is essential to continuously refine evaluation standards, strengthen regulatory collaboration, and strike a dynamic balance between innovation and accessibility.

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