Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 87

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 87
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 differences between the biosimilar and the reference product in terms of safety, quality and efficacy. Appropriate pre-clinical tests or clinical trials relating to these conditions must be provided.

In 2023, the European Commission published proposals to revise the existing EU legislation on pharmaceutical products (the “EU Pharma Law Review”). These proposals comprise a new directive and a new regulation (the “EU Pharma Law Proposal”) that are intended to replace the current legislation concerning medicinal products for human use, including legislation concerning orphan medical products and medicinal products for pediatric use. Amongst other proposed changes to the current legislation, the EU Pharma Law Proposal as presented by the European Commission proposes that the European authorities will be able to refuse an MAA where the accompanying Environmental Risk Assessment (“ERA”) is not adequate, or if the environmental risks have not been sufficiently addressed. 

European Union Data and Marketing Exclusivity 

The EU also provides opportunities for market exclusivity. Upon receiving an MA, new chemical entities generally receive eight years of data exclusivity and an additional two years of market exclusivity. If granted, data exclusivity prevents regulatory authorities in the EU from referencing the innovator’s data to assess a generic or biosimilar MAA. During the additional two-year period of market exclusivity, a generic or biosimilar MA can be submitted, and the innovator’s data may be referenced, but no generic or biosimilar product can be marketed until the expiration of the market exclusivity. The overall ten-year market exclusivity period may be extended to a maximum of eleven years if, during the first eight years a new therapeutic indication with significant clinical benefit over existing therapies is approved. However, there is no guarantee that a product will be considered by the EU regulatory authorities to be a new chemical entity, and products may not qualify for data exclusivity. 

The EU Pharma Law Review could have a significant impact on the regulatory data exclusivity protection (“RDP”) for innovative pharmaceutical products in the EU. If adopted in its current form, the EU Pharma Law Proposal would reduce the current baseline for data exclusivity from eight to six years, extendable under certain conditions. Such RDP reduction could lead to faster access to the EU market for generics and biosimilars. 

European Union Orphan Drug Designation and Exclusivity 

Products receiving orphan drug designation in the EU can receive ten years of market exclusivity once they are authorized as orphan medicines. During the ten-year market exclusivity period, the EMA cannot accept another application for a MA, or grant a MA or accept an