Experience of using interferon β-1a biosimilans (cinnovex and genfaxon-44) in the Moscow Multiple Sclerosis Center

Abstract

The high percentage of withdrawal of treatment due to the lack of clinical effect and intolerance to the drugs was identified during the treatment. Positive effect with respect to stabilization of MS course was found only in patients who earlier did not receive disease-modifying drugs. Double-blind studies are needed to resolve the question of the adequacy of brand-name drugs and generics.

Clinical implications for substandard, nonproprietary medicines in multiple sclerosis: focus on fingolimod

“…CinnoVex™ (CinnaGen, Tehran, Iran) and Genfaxon ® (Genfa, Geneva, Switzerland), two biosimilars of the proprietary β-interferons Avonex ® (Biogen Idec Inc., Cambridge, MA, USA) and Rebif ® (EMD Serono, Inc., Rockland, MA, USA) are available commercially in Russia and Ukraine. 26 , 27 In clinical trials, CinnoVex was shown to be less effective than Avonex, while Genfaxon displayed an unfavorable tolerability profile compared with Rebif. 26 , 27 Adverse events included the development of flu-like symptoms, local skin reactions, and mood changes and were reported more frequently than for Avonex or Rebif.…”

“… 26 , 27 In clinical trials, CinnoVex was shown to be less effective than Avonex, while Genfaxon displayed an unfavorable tolerability profile compared with Rebif. 26 , 27 Adverse events included the development of flu-like symptoms, local skin reactions, and mood changes and were reported more frequently than for Avonex or Rebif. Nonproprietary biosimilars undergo a three-stage assessment of pharmaceutical quality, laboratory testing, and clinical data to ensure similar safety and efficacy to the proprietary medicine.…”

“…In MS, which is treated using immunomodulatory medicines, substandard copies can expose patients to unnecessary risks, as demonstrated by reports of efficacy and tolerability problems with β-interferon biosimilars. 26 , 27…”