Breaking Down the Challenges of Complex Generics

Complex generics is a lucrative and attractive market as it distinguishes itself from the simple generics market in providing additional value to the patients by addressing their unmet needs, but at the same time, it is challenging, time-consuming, and expensive for the manufacturers to develop and demonstrate the bioequivalence, safety, and efficacy of the complex generic drugs.

Strategic partnership with the right Regulatory partner can help biopharma companies to identify future challenges and build appropriate Regulatory and product development strategies to avoid compliance risk and increase the chance of generic application approval.

At Freyr, we support our clients throughout the drug product’s lifecycle starting from product development (including pre-submission activities) to dossier gap analysis, generic CMC activities, and lifecycle management. Our Regulatory affairs experts understand different Regulatory requirements for different types of complex generic drugs and incorporate them during the development stage plan to develop safe and quality complex generic drugs ensuring rapid entry of the drug into the market and gain limited exclusivity.

Latest Resources

  • Blogs

    API Guidance Notes – Decode NPRA Malaysia Guidance

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  • White Papers

    Control of Nitrosamines in Drug Products Regulatory Considerations

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  • Past Webinars

    Competitive Generic Therapies (CGT) - FDA Requirements

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