- Developing a deep understanding of the regulatory requirements for the target market.
- The lack of regulatory guidance introduces uncertainty, emphasizing the importance of early and consistent interactions with regulators.
- Planning and study design for complex generics pose challenges due to the need for extensive clinical trials beyond simple generic products
- Consideration must be given to factors such as time, location, and recruitment costs.
- Biopharma companies should approach complex generics projects strategically, similar to innovative drug development.
- Selecting suitable sites for complex generics projects is challenging, requiring evaluation of capabilities and commitment to compliance.
- Rushing the development phase and working with inexperienced sites or manufacturers increase compliance risks.
- Meticulous methods and testing are necessary for complex generics to meet efficacy and compliance goals.
- The transition from pilot to manufacturing introduces compliance challenges, as processing issues can affect consistency and product quality.
- Biopharma companies must carefully assess their capabilities and commitment to compliance rules, despite pressure to reduce time and costs.
- Adherence to good manufacturing practices is crucial to avoid regulatory issues that could delay approval.
- Neglecting proper methods and testing during development increases compliance risks.
- Complex generics projects require rigorous testing and nuanced methods, facing additional compliance risks during the transition to manufacturing.
- Prioritizing compliance is necessary for successful development, particularly in complex generics.
- Biopharma companies should conduct research on similar approvals to gain insights into the regulatory landscape and necessities for complex generics.
- Following relevant regulations is crucial in the development and approval process of complex generics, and adherence to Good Regulatory Practice (GRP) guidelines is essential.
- Seeking feedback from regulatory authorities is valuable as it helps refine the development plan and optimize the approval process for complex generics.
- Adopting a comprehensive and strategic approach is necessary for successful planning and study design of complex generics.
- Biopharma companies should carefully select experienced partners to collaborate with on complex generic trials.
- Investing in suitable trial sites and infrastructure is important to ensure the smooth execution of complex generic trials.
- Emphasizing the value of the trial, both in terms of scientific contribution and potential benefits to patients, can facilitate recruitment and engagement.
- Starting site outreach early in the trial planning phase helps establish strong collaborations and increases the chances of successful complex generics trials.
- A compliance plan is crucial for complex generic projects to ensure adherence to regulatory requirements and standards.
- Including a dedicated compliance expert in the development team can help navigate complex regulatory landscapes effectively.
- Maintaining a balance between speed and compliance is essential to protect the brand reputation and ensure patient safety during complex generic projects.
 US FDA. Complex Generics News. United States Food and Drug Administration. 2023
EMA. Generic and Hybrid Medicines. European Medicines Agency. 2022
 Klein K, Borchard G, Shah VP, Flühmann B, McNeil SE, de Vlieger JS. A pragmatic regulatory approach for complex generics through the US FDA 505 (j) or 505 (b)(2) approval pathways. Annals of the New York Academy of Sciences. 2021 Oct;1502(1):5-13.