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Expired patent medicines: the knots to untie

The Italian legislative process concerning generic medicines has caused profound consequences both on the market and on the medical profession, with positive aspects but also critical situations. The latter were discussed in Milan, in a conference on expired patent drugs organized by the Italian Pharmacology Society (Sif), in which the gray areas relating to biosimilars were therefore also addressed. Among the new or unsolved problems, Francis Rossi, president-elect of Sif, identifies that of interchangeability: «the current approval procedures for generics do not guarantee that two or more equivalents of the same brand are really equivalent to each other, because the bioequivalence range could be beyond the pre-set limit, even though both are within the range with respect to the originator. Furthermore, the acceptable range of bioequivalence may not be suitable for drugs without large margins of handling". Instead, he focused on the problems caused to the family doctor by substitutability Robert Stella, president of Snamid. «It is a criterion that can increase mistakes and disputes since» in the event of any damage arising from the use of a substituted drug «the responsibility remains with the prescriber, and there is no discharge of liability on the pharmacist or the patient. Furthermore, especially in the case of elderly and frail patients, switching (due to the size and color of the packs) can cause confusion and non-adherence to therapy". Lucia Aleotti, vice president of Farmindustria, underlined the damage done to the industry engaged in research, which is important for the country's economy, by the rule relating to the obligation to write the name of the active ingredient on the recipe, contained in the Balduzzi decree with a view to spending review. «This obligation» says Aleotti «does not offer any savings to the NHS, as reimbursement is already in force up to the competition at the lowest price». As for biosimilars, Walter Torri, of the Mario Negri Pharmacological Research Institute of Milan, hypothesizes the use of Bayesian statistical methods to carry out, with a very limited number of patients, randomized and non-inferiority "phase II" studies to make up for the current European registration deficiencies in terms of efficiency and safety.

April 8, 2013 – DoctorNews33

Expired patent medicines: unsolved problems and proposed solutions
Third Conference – Patronage of SIF
Milan, April 5th 2013

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco