Sunday, 9 September 2018

A beta interferon me-too is just as good as the original

We have been talking about the differences between the original and generic variants. This study looks at the effect of Cinnovex and Avonex and finds no difference.


Pakdaman H, Abbasi M, Gharagozli K, Ashrafi F, Delavar Kasmaei H, Amini Harandi A. A randomized double-blind trial of comparative efficacy and safety of Avonex and CinnoVex for treatment of relapsing-remitting multiple sclerosis.Neurol Sci. 2018. doi: 10.1007/s10072-018-3550-8. [Epub ahead of print]

BACKGROUND AND AIM: Interferon beta is currently the first line treatment of relapsing-remitting multiple sclerosis (RRMS). Different formulations of interferon beta are available. Avonex and CinnoVex are two interferon beta-1a being prescribed by neurologists in Iran. The aim of this study was to compare the four and half year outcome of Avonex and CinnoVex in patients with RRMS.
METHODS:A total 186 of patients with definite RRMS diagnosis were followed for four and half years. Patients were randomly assigned to receive either Avonex or CinnoVex. Patients were subsequently visited every 6 months, and MRI was also undertaken prior each visit. The efficacy end points were to compare mean scores of expanded disability status scale (EDSS) and the proportion of patients with MRI and clinical activity in follow-up visits between Avonex and CinnoVex. Safety end point was to compare the percentage of adverse events between two groups.
RESULTS:One hundred and eighty-two patients completed the study. The population of study experienced a steady increase in EDSS during follow-up with a mean increase of 1.03. Repeated measures ANOVA revealed no statistically significant difference between Avonex and CinnoVex (p = 0.78). The most common adverse events were headache, myalgia, fatigue, fever, flu symptoms, injection site pain, and depression. Direct comparison of each adverse events revealed no meaningful difference between two groups except for only a few adverse events. There was no statistically significant difference in MRI activity and clinical activity between two groups.
CONCLUSION:Avonex and CinnoVex showed similar efficacy and safety outcome in patients with RRMS.

You may not have heard of Cinnovex, that is unless you live in Iran. If you live in Iran this may give you comfort that your home grown variant is as good as the American alternative.

Iran is a hot bed of MS, but it has been an international pyriah for many years. Many things were embargoed by the West, notably the USA. 

A few years ago American Journals were banned from accepting Iranian Scientist's work, if they were government sponsored:-(.

However, if you are seen as the "Worlds' bad lads" and you are banned from getting Western Goods, you can either do nothing for your population or you can say "Stuff the Global Patent System" and make your own drugs. 

This is what Iran does "allegedly" and Cinnovex is one example of this. 

It is good that Iranian Neurologists have done a formal trial to show that their generic is as good as the original version. 

The beta interferon patents have now expired so maybe they feel OK reporting this. However I have heard that Iran has produced their own Iranian fingolimod and cladribine. So good news for people with MS in Iran as I guess they have treatment options.

1 comment:

  1. Bravo! Great to see something positive rather than just the usual Iranian political impass and global impasse. I guess if you are already santioned for everything, there is no point worrying about the implications of patent/copyright infringements.

    Hooray for cures not politics.

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