by Robert Galbraith

ROME, 29 Mar (APM) - The Italian medicines agency has introduced an important change to biosimilars regulation, opening the way for interchangeability with originator drugs regardless of whether a patient has already started treatment or not.

The new direction is the result of a second position paper on the subject which was presented during a meeting in Rome on Tuesday, organised by the regulator to discuss the changes with stakeholders. An Ernst & Young study was presented at the same event showing that around 200,000 patients in Italy may be missing out on treatments with biological drugs (APMMA 57503).

AIFA’s first position paper in 2013 excluded any automatic substitution of biological products with biosimilars. It recommended that biosimilars should be preferred when there was an economic benefit, especially in treatment-naïve patients.

The second position paper on biosimilars came out of a lengthy public process started in 2016 and involved consultation with scientific societies, health operators, regional bodies, patients and civic associations, industry bodies and four pharmaceutical companies. It received around 200 comments.

The key difference between the first and second paper is interchangeability. AIFA noted that the regulatory authorisation process demonstrates that the risk-benefit of biosimilars is the same as for reference originators.

“For this reason, AIFA considers biosimilars as interchangeable products with the corresponding reference originators. This consideration is valid both for naïve patients and for patients already under treatment,” the regulator states in the latest position paper.

AIFA has also indicated that doctors need to take into consideration the cost of treatments prescribed. “While the choice of treatment remains a clinical decision entrusted to the prescriber, the latter is also entrusted with the task of contributing to an appropriate use of resources for the sustainability of the health system and the correct information of the patient on the use of biosimilars,” it said.

AIFA’s director general Mario Melazzini, who presented the paper at the Rome meeting, said it should be seen as a starting point, adding that consultation will continue. He suggested that a new approach is required to keep spending sustainable and to ensure that biological drugs are available to all patients at the same time.

"Biosimilars are an indispensable tool for the development of a competitive market that produces healthcare because they are a lower-cost therapeutic option for the National Health Service (SSN),” Melazzini told the meeting. “This will involve treating a growing number of patients and guaranteeing access to therapies with high economic impact while having potential savings not only in terms of health costs but also social costs.”

Simona Montilla, health director in AIFA’s research department, suggested that Italy is moving into line with other EU countries. “Although the EMA has not expressed recommendations about the interchangeability of biosimilars with reference biologicals, the member states are moving in that direction,” she said.

Montilla described the current the situation in four different countries:

• In France, interchangeability is allowed during treatment as long as the patient is informed and monitored appropriately
• In Germany, biosimilars can be used for the same indications as the reference drug and for those which it has been demonstrated to be equivalent in both naïve and non-naïve patients
• In Norway, medical practice is for the prescriber to substitute a drug with another which has the same clinical effect in specific clinical settings and for all patients
• In Portugal, it is recommended to choose a biosimilar (instead of the reference drug) whenever possible.

rg/clg