Italy looks to multi-stakeholder alliance to build consensus on biosimilars

by Robert Galbraith
ROME, July 19 (APM) - Italy is hoping a multi-stakeholder alliance, including pharma, patients, regulators and scientific experts, can create more consensus about how to use biosimilars to their best effect.
The Italian Biosimilars Group (IBG) held a conference at the Senate library in Rome on Friday to present its report on the conclusions of a working group which was set up to look at all the issues connected to biosimilars. The 'consensus paper' which resulted has highlighted agreement about many regulatory and clinical aspects but also the need for more effective communication.
The IBG initiative comes after the Italian medicines agency AIFA published a second position paper on biosimilars in June to include recent developments including its therapeutic equivalence guidelines. A consultation process will continue until September 15 to allow comments and proposals before the definitive version of the regulator's paper is issued.

Biosimilars needed to improve access

In his address to the Rome meeting, AIFA's president, Mario Melazzini, stressed the need to consider all the potential effects of biosimilars especially on ways to improve access to innovative products for patients. "We must not make the mistake of seeing these drugs exclusively as providing savings and sustainability," he told the meeting.
He said the best use of biosimilars will only be possible if information and education are increased. "We must use all available resources to acquire the largest number of evidences and extend the banks of knowledge for doctors and patients," he said.
IBG coordinator, Manlio Florenzano, told the conference that an alliance which involves all interested parties is necessary to overcome resistance to biosimilars. "The safety and efficacy of biosimilar drugs has been demonstrated both by clinical studies in registration and daily clinical practice and yet there is still uncertainty about their use," he said.

Sharing real world evidence important

Florenzano suggested that not enough has been done to share real world evidence about biosimilars which would help bridge the information gap. "The benefits from using biosimilars have not been adequately explained to show that they don't just generate savings but also significantly widen access to the best currently available treatments," he told the meeting.
To produce the consensus paper, IBG brought together 38 experts including clinicians, patient representatives, pharmacologists and regulatory officials. They looked at four different aspects of biosimilars use: comparability exercises, indication extrapolation, switching and the need to define naive patients.
Massimo Morosetti, director of the nephrology and dialysis unit at Ostia's Giovan Batista Grassi hospital, reported on their findings. He told the meeting that some issues, such as doubts about switching and whether to categorise native patients, have become less problematic.
The group looking at comparability exercises concluded that they are generally reliable and effective and that evidence required by the European Medicines Agency (EMA) and its Italian counterpart, AIFA, is adequate to the task.
However, Morosetti said that patients' representatives had highlighted the need for informal meetings with AIFA officials without pharma companies or clinicians being present. This would allow for doubts and concerns about biosimilar drugs to be better resolved, he added.

Doubts about extrapolation of indications

The group considering indication extrapolation specifically examined the case of Merck & Co/Johnson & Johnson's Remicade (infliximab) noting that scientific societies have tended to question EMA's policy of approval its biosimilars for the same indications as the originator. This group concluded that it would be better to look at use of clinical comparability of biosimilars on a case by case basis.

Switching no longer seen as a problem

The expert discussion on switching, substitution and interchangeability of biosimilars concluded that data from clinical use of those products which have been on the market for longest demonstrate that there are no problems.
However, the group was unanimous in ruling out multiple switches of a drug because of the difficulties it might cause in traceability and assessing long-term side effects. It was also stressed that the final decision about which treatment to use must be the clinician's
The fourth group concluded that whether to put naive patients in a separate category is an issue which has been superseded in clinical practice. The experts said that no longer differentiating would help in providing information about biosimilars and make clinical functions more efficient.



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