White & Case antitrust partner Eileen Cole spoke to the Financial Times about differences between Europe's and the US's approach to drug patents and regulatory exclusivities for biologics and biosimilars.
Cole explained that such exclusivities seek to spur innovation: "Without such protections, pharmaceuticals could not profit from their labor. These exclusivities are intended to incentivize pharmaceutical companies to innovate."
The regulatory framework also provides a pathway for biosimilar development and approval. Cole explained: "Other manufacturers are able to develop their own treatments that are biologically similar. These biosimilars then need to be registered with and approved by regulators before they can enter the market and compete with the original treatment."
Cole also told the FT that the importance of innovation by drugmakers came under the spotlight during the race to develop vaccines during the COVID-19 pandemic. She notes: "Pharma companies who had techniques in place based on their R&D were able to quickly turn and focus on the issue at hand."
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