Sandoz’s biosimilars rituximab, etanercept receives positive opinion from CHMP

Measuring lung function is an important component in the diagnostic process for patients with suspected lung function abnormalities such as chronic obstructive pulmonary disease ("COPD") and asthma.  Not only does it help identify a specific diagnosis, it also provides valuable information regarding the severity of the condition so that appropriate therapy, including inhaled medications can be prescribed. Currently, spirometry is the most common lung function test, however, spirometry is not an easy test to perform because it requires repeated forced breathing maneuvers, good patient co-operation and a skilled technician.

Todd M. Austin, chief executive officer of MGC Diagnostics commented, "We are excited about the opportunity to sponsor this large clinical study and our continued collaboration with Restech Srl, the manufacturer of the Resmon Pro Full device. We believe that the results of this clinical study will advance the widespread adoption of the Resmon Pro as a valuable tool for the diagnosis and management of COPD and asthma."

"The main advantage of this technology is the elimination of repeated, forced breathing maneuvers. The FOT test allows the patient to breathe normally, at rest and with minimal technician instruction required. Not only is FOT easy to use, it provides unique information about lung function not available with conventional spirometry," concluded Austin.

The multi-center, observational prospective accuracy study objective is to determine the diagnostic accuracy of within-breath FOT parameters, measured or calculated by the Resmon Pro Full, to detect a lung function anomaly as compared to spirometry in a prospective and consecutive cohort of subjects attending a pulmonary function testing lab for diagnostic examination. Sensitivity and specificity analysis along with the results of the trial will be compared with spirometry, considered the "gold standard," to confirm the presence of a lung function anomaly.

Restech Srl is a spin-off from Milan Polytechnic University, established in 2010 by the Biomedical Technologies Laboratory (TBM Lab) in the Department of Bioengineering. For several years, the department has been focusing its research effort on developing new technologies for investigating the pathophysiology of the respiratory system and respiratory medicine more generally. Restech's mission is to develop highly innovative medical devices and solutions in the respiratory sector, from research to product engineering, manufacturing and marketing. The company has designed and manufactures the Resmon Pro Full, a FOT based professional device for the assessment of lung function.

Sandoz’s biosimilars rituximab, etanercept receives positive opinion from chmp