Landscape Analysis of Generic Availability for Oncologic Drugs
Vaibhav Kumar1, Fenggong Wang2, Meng Hu2
1Division of Oncology 3, Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Therapeutic Innovation & Regulatory Science
|August 10, 2023
Summary
Generic oncology drugs face longer development timelines compared to cardiovascular drugs. Key factors influencing generic availability include drug complexity and regulatory requirements, such as patient enrollment for bioequivalence studies.
Area of Science:
- Pharmacoeconomics
- Drug Development
- Oncology Therapeutics
Background:
- Generic drug development is crucial for affordable cancer care in the US.
- Factors influencing generic oncology drug development differ from other therapeutic areas.
- This study compares generic competition in oncology versus cardiovascular disease.
Purpose of the Study:
- To assess variables influencing generic drug competition in oncology.
- To compare generic drug development timelines between oncology and cardiovascular indications.
- To identify factors associated with abbreviated new drug application (ANDA) availability.
Main Methods:
- Utilized FDA and public data for drug approvals (1950-2021).
- Employed machine learning to identify variables linked to ANDA availability.
- Used Kaplan-Meier and Cox regression analyses to compare time to generic approval.
Main Results:
- Fewer oncology drugs (49%) had generics compared to cardiovascular drugs (80%).
- Oncology drugs had a longer median time from reference listed drug (RLD) approval to first ANDA approval (15.4 years vs. 12.3 years).
- Product dosage form and bioequivalence (BE) study requirements (e.g., patient enrollment) were associated with reduced ANDA approval likelihood for oncology drugs.
Conclusions:
- Oncology drugs experience significantly longer times to generic availability than cardiovascular drugs.
- Regulatory recommendations, particularly for bioequivalence (BE) study design, represent a key area for stakeholder engagement.
- Understanding these variables can inform strategies to improve generic oncology drug development and patient access.
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