India gets low cost biosimilar of Remicade

[Fred]

A question regarding biosimilars are their any restrictions on where they can be sold?
What I mean is are we likely to see price wars or pressure on the other drugs to reduce prices?

My understanding is that they can only be sold in the country they are approved for, they have to go through the same tests as the original to be deemed suitable under that countries regulations.

So in India both will be available but Infimab will be offered as a cheaper alternative, but as it's not approved for use say in the UK then it will still be Remicade that UK residents will get.

So will the biosimilar companies go for approval in other countries or will they stay where approval is easier

I would imagine they will go for where the market is, somewhere like India needs cheaper drugs but other countries would probably make it difficult for them.

Take here in France for example we are usually last to get new treatments as the French tend to hold back and wait and see, USA are usually first to give approval then Europe. But even if it gets approval by Europe the French will still conduct there own trials before going live.

They are now only just starting a program of testing for Fumaderm and it's not widely available, and won't be a for a while yet. I asked why they take so long and I got the impression it was let's see how what problems other countries get and let them do the donkey work, then we can do our own tests knowing what to look out for.

So I think it would be very difficult Infimab to get approval in France and if they did it would take a long time, whereas somewhere like Romania may be a better option for them.