Reference Listed Drugs (RLDs) are brand-name medications that have been approved by regulatory
agencies, such as the FDA or EMA, and serve as the benchmark for evaluating the safety, efficacy, and
quality of generic or biosimilar products. They play a crucial role in the pharmaceutical industry,
particularly in the development and approval of generic drugs and biosimilars.
Role of RLDs in Clinical Trials:
In order to market a generic drug or biosimilar, manufacturers must conduct a head-to-head comparison,
known as a comparability exercise, between their product and the corresponding RLD. This process
focuses on:
- Establishing similarities and differences between the generic/biosimilar and the reference product
- Differences in their manufacturing approaches
Regulatory approval for a generic drug or biosimilar can only be obtained by demonstrating
bioequivalence to the designated RLD. By designating a single RLD as the standard, regulatory
authorities aim to ensure consistency among generic products and their brand-name counterparts. This
consistency is crucial for:
- Maintaining the safety and efficacy of medications
- Promoting patient confidence in generic drugs and biosimilar
Challenges in Sourcing RLDs:
Sourcing RLDs can be a complex challenge for pharmaceutical companies and clinical trial sponsors.
RLDs are often subject to restricted distribution programs, making them difficult to obtain in the quantities
and timeframes required for clinical trials and analytical purposes. Additionally, RLDs may have specific
storage and handling requirements, such as:
- Temperature and humidity controls
- Must be maintained throughout the sourcing and delivery process
Solutions for Sourcing RLDs:
To overcome these challenges, pharmaceutical companies and clinical trial sponsors often rely on
specialized RLD sourcing companies, such as Ikris Pharma International. IPI provide:
- Extensive networks of suppliers and distributors worldwide
- Ability to procure RLDs from multiple sources
- Reliable supply
- Comprehensive documentation packages to meet regulatory requirements
- Full-service solutions from sourcing
Regulatory Compliance:
In addition to sourcing RLDs, pharmaceutical companies and clinical trial sponsors must also ensure that
they comply with all relevant regulatory requirements for the procurement and use of RLDs. This
includes:
- Adhering to current Good Distribution Practices (GDP)
- Implementing stringent quality control measures
- Preventing diversion or misuse of controlled substances
Future Outlook:
The global generics drug market is anticipated to grow significantly in the coming years, driven by factors
such as:
- Increasing prevalence of chronic diseases
- Rising cost of healthcare
- Expiration of patents on brand-name drugs
As a result, the demand for RLDs is expected to continue to rise, making it increasingly important for
pharmaceutical companies and clinical trial sponsors to have reliable access to these critical reference
products.
Reference Listed Drugs (RLDs) are essential for the development and approval of generic drugs and
biosimilars, as well as for ensuring the consistency and quality of medications in the pharmaceutical
industry. While sourcing RLDs can be a complex challenge, specialized sourcing companies and
adherence to regulatory requirements can help ensure a reliable supply and successful clinical trials. As
the global generics drug market continues to grow, the importance of RLDs will only become more
pronounced, making it crucial for pharmaceutical companies and clinical trial sponsors to prioritize RLD
sourcing and compliance.
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