The Italian Finance Bill for 2017: Important News Regarding Biosimilars

MILAN, December 14, 2016 /PRNewswire/ --

The 2017 Finance Bill, recently approved by the Republic of Italy's Senate, includes important provisions favouring biosimilar medicines, a significant landmark that will increase competition among biotech drug companies.

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With a view to rationalising the cost of biopharmaceuticals whose patents have expired, regional buying centres will be required to prepare a single batch that takes into account the same active ingredient, the same dosage and medicines that are taken in the same way. Furthermore, public purchasing procedures will need to be conducted using framework agreements with all the companies who own medicines when there are more than three medicines with the same active ingredient.

Also with a view to improving cost rationalisation and the wider availability of treatments, the Bill states that patients will need to be treated with one of the first three medicines listed in the framework agreement, on the basis of the cheapest or best value for money, though doctors will still be free to prescribe other medicines to ensure therapeutic continuity.

Last but not least, should a biotech medicine's patent or supplementary protection certificate expire during the time the supply contract is still valid, the contracting authority is required to reopen the competitive tender process no later than 60 days after one or more biosimilars with the same active ingredient come on the market.

"This new draft law is an important landmark that encourages a more dynamic market for biotech medicines and makes more room for biosimilar drugs, with a view to guaranteeing a true rationalisation of the Italian national health service's resources", said Marco Filippini, Mundipharma Italy General Manager, France & Southern Europe Regional Director and Vice Coordinator of the Italian Biosimilars Group (IBG), a member of Assogenerici, the Italian Association of Generic and Biosimilar Drug Producers. "To this end, it is essential that the savings obtained in this way are not 'frozen' by regional governments and are instead made available to patients, who need access to treatment, or are used to purchase innovative medicines that allow an increasingly targeted approach to treatment. In this way, we are not talking about savings for savings' sake, but rather about re-investment that can improve the access to treatment."