Italian Finance Bill for 2017: Important news regarding biosimilars

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

With a view to rationalizing the cost of biopharmaceuticals whose patents have expired, regional buying centers 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 rationalization 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.