USA – The FDA’s Office of Generic Drugs (OGD) and the European Medicines Agency (EMA) have initiated a new pilot programme to streamline the development of complex generic drugs and enhance patient access to essential medications.
This collaborative effort builds upon the foundation of the parallel scientific advice (PSA) programme established by the two regulatory agencies in 2021.
The voluntary pilot programme specifically targets complex generics, often referred to as ‘hybrid medicines’ by the EMA.
These medications, usually small molecules, contain the same active substance as an authorized medicine but may exhibit differences in strength, indication, or pharmaceutical form and are commonly utilized in the treatment of various conditions such as cancer, rheumatoid arthritis, and multiple sclerosis.
Originally launched in 2005, the PSA programme serves as a platform for sponsors of new medicines to seek guidance from both the FDA and EMA on scientific matters related to product development.
The new initiative aims to facilitate concurrent discussions between generic drug manufacturers and regulatory bodies, with the overarching goal of improving patient access to harder-to-develop generic drugs.
To participate in the PSA programme, applicants are required to submit requests to both the EMA and FDA.
Suitable candidates for this programme include proposals for single bioequivalence studies, approaches with common comparators, and the utilization of modeling and simulation data to enhance development efficiency.
While complex generic drugs present significant market opportunities due to fewer competitors and higher profit margins, manufacturers face challenges in both manufacturing and regulatory processes.
The collaborative effort between the EMA and FDA seeks to alleviate some of these challenges by providing early engagement with regulatory agencies, enhancing the scientific quality and validity of generic drug development plans, and reducing the risk of regulatory hurdles or surprises later in the process.
In recent years, the markets for biosimilars—alternate versions of biologics—have evolved differently in the US and EU, with the EU market witnessing a greater proliferation and utilization of biosimilar products, resulting in increased competition and lower prices.
Conversely, in the US, factors such as payer and physician perceptions, pricing, and rebates greatly influenced the uptake of these biosimilars.
The collaboration between the FDA and EMA is by far a significant step forward in harmonizing regulatory approaches and fostering innovation in the development of generic drugs, ultimately benefiting patients by ensuring timely access to safe, effective, and affordable medications.