Small Molecules and Generics

Product development of new generic molecules starts early in the life cycle of the originator product (at the time of market launch) so long-term planning is essential and mainly based on product patent expiries. 

The European Medicines Agency (EMA) defines a generic drug as a medicine that is developed to be the same as a medicine that has already been authorized. It contains the same active substances and is used at the same doses to treat the same diseases as the reference drug.  

EMA refers to complex generics as “hybrid medicines”, whose “authorization depends partly on the results of tests on the reference medicine and partly on new data from clinical trials.” 

For small-molecule generics, the development and manufacturing processes are in most cases straightforward. Generic manufacturers only need to prove that the product contains the identical chemical composition of the innovator product and demonstrate similar pharmacokinetic properties with a bioavailability study. 

However, the development of complex generics in an era of rising costs, increased focus on global developments and manufacturing operations requires a higher level of expertise. It demands more detailed planning and a deep understanding of the regulatory, quality, and clinical aspects of small molecule development to bring these drugs to the market. 

A sound understanding of the applicable scientific and regulatory EMA and ICH guidelines for the development of small molecule-based medicinal products is therefore required. 

The QbD RA Team can support developers of small molecules to ensure the CMC (Chemistry-Manufacturing-Control) section of the registration dossier (CTD Module 3) is as per regulatory expectations. 

Furthermore, the regulatory life cycle of small molecule marketing authorizations can be resource-intensive and once the registration is obtained multiple variations on annual basis are expected to be prepared and submitted. These variations could be quality-driven (drug substance/drug product) or safety-related. 

Irrespective of the type of variation, the QbD RA team can support MAH with the full life cycle management for your marketing authorizations.