Generics development and registration: A Deep dive into the CMC aspects and ensuring the sameness of the generic to the originator reference product

Generics market covers more than 50% of the global pharmaceutical market. Generics are essential to ensure widely available treatment options accessible to all patients. Governments and Public Payers rely on generics to contain the pharma expenditure and the growing rate of chronic diseases is expected to further boosts the generic drugs market worldwide.

Generics development is a complex process aimed at ensuring sameness to the originator reference product, comparable performances and therapeutic equivalence. The first brick of a generic drug development starts with a proper selection of the source of the Active Ingredient, a deep study of the pharmaceutical formulation and its performances and characteristics such as stability and the impurities profile, in other words the Chemistry Manufacturing and Controls of the drug formulation. Let’s explore the CMC’s most critical aspects for ensuring a successful and robust pharmaceutical development of generic medicines.

Claude Vella Bonanno

Graduated as a pharmacist in 2005, I have been working in the pharmaceutical industry since 2006. I started in the API industry, specifically on corticosteroid production. This has allowed me to learn the basics of GMP and to develop skills areas such as validation. I have also developed my skills as an internal and external auditor. Moreover, I was responsible for setting up a new manufacturing plant exposing me to areas such as engineering and project management (Transfer of Technology).

In 2010, I moved to Business Development, adapting these skills in combination with the synergies provided by other suppliers to offer packages to clients. After 8 years in the API industry, I moved to the Pharma Finished Dosage Forms industry, where I headed the Quality Assurance team, including a group of 4 Qualified Persons and a number of inspections including EU GMP and FDA successfully. After two years, I moved to the GDP industry, where I worked for a number of multinationals such as J&J, Celgene and BMS as a Responsible Person. Finally, I set up my own services company called Quintian Pharma, offering QA and PV services (I am a registered EU QPPV) and providing audits in the GMP, GDP and GVP areas. I also provide importation Responsible Person (RPi) services for virtual Wholesale Dealers. I have also undergone training at the ECA Academy to become a GMP auditor.

Paola Cinquanta

Paola Cinquanta has more than 10 years’ experience long career in Regulatory Affairs for highly regulated products. Graduated at the University of Milan with a degree in Pharmaceutical Biotechnology and a Specialization in Regulatory Affairs. Spent her career in several pharmaceutical companies ranging from generic drugs and biosimilars development, to innovative biopharmaceutical industry with role of Project Manager. Possesses extensive experience in Regulatory Affairs. Paola possess wide knowledge of MAA request via Centralized Procedure/MRP as well as NDA/BLA and NDS; ODD, preparation of CTA/IMPDs/INDs for Ph 1-3 studies; pre-/post registration of ODAs and PIPs, PSURs, etc.

Her specialty is Oncology, GvHD; Transplantation; Anesthesia, Pain, CNS and Anti-Infectives. She joined PQE in 2018 as Executive Consultant, in 2022 she took-up the position of Regulatory Affairs Operations Manager and Senior Associate Partner coordinating the Regulatory Affairs Teams at global level.

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