BIOLOGICS INVESTMENT PROGRAMME RDI (RSFF)

The project concerns the development of biosimilar and biobetter medications.

To provide more affordable alternatives to current treatments and give patients easier access to modern biological drugs within a new segment of the pharmaceutical market, whose approval requires extensive clinical trials (in comparison to other generic products). The extensive trials are necessary to prove bioequivalence and similarity to the original biological drugs, based on strong research and development efforts. EIB financing of the project corresponds to the Community’s role to encourage Research and Technological Development as defined in Article 179 of the EC Treaty and with the “Common Interest” criterion under the Treaty’s Article 309 point (c), i.e. the Bank’s financing activities under the Knowledge Economy (i2i), research & development.

The project mainly concerns investments in R&D that are expected to be carried out in existing facilities already authorised for the same purpose and would therefore not require an EIA under the Directive 2011/92/EU. Full environmental details will be verified during the appraisal.

The promoter is a private company not operating in the Utilities sector and not having the status of a contracting authority. Thus it is not covered by EU Directives on procurement. However, the promoter’s procurement procedures are expected to be in line with EIB guidelines for private sector projects. The Bank’s services will verify details during the project due diligence.