Complex Generics
A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Medicinal Chemistry".
Deadline for manuscript submissions: closed (31 January 2021) | Viewed by 899
Special Issue Editor
Interests: biosimilars; RNA therapeutics; formulations; bioequivalence; complex generics; regulatory optimization; intellectual property; biotechnology; gene therapy
Special Issues, Collections and Topics in MDPI journals
Special Issue Information
Dear Colleagues,
Developing complex generics in an era of rising costs and increased scrutiny of international development and manufacturing operations requires a higher level of expertise than is required for simple generics development. It demands a more sophisticated planning and development process, and a deep understanding of the regulatory, quality and health technology assessment (HTA, pricing/reimbursement) environment to bring these drugs to market. Generics developers who can adapt their clinical development to address these added challenges while still achieving speed to market can benefit from exclusivity and considerable return on investment. While cheaper than branded options, complex generics offer biopharma companies the opportunity to capture additional value commensurate with the associated additional risk and patient benefit.
The FDA defines a generic drug as one that is identical—or bioequivalent—to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. The EMA refers to complex generics as “hybrid medicines”, whose “authorisation depends partly on the results of tests on the reference medicine and partly on new data from clinical trials”.
The fast emergence of new technologies in this lucrative market requires a new review and sharing of experience.
Dr. Sarfaraz K. Niazi
Guest Editor
Manuscript Submission Information
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Keywords
- complex generics
- generic medicines
- bioequivalence testing
- formulation complexity
- regulatory compliance
