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Biosimilars

These medicines are similar to generics but with the key difference being that the medicine going off-patent is derived from a biotechnology product (biopharmaceutical).

With biopharmaceuticals losing their patent protection this means that they can be developed and manufactured by other companies.  This in turn ensures that patients have access to safe, effective and more affordable biotechnology-derived medicines.  Biopharmaceuticals cost about twice as much as conventional pharmaceuticals and many patients who need biopharmaceutical treatment are unable to do so because of cost.  

Although a biosimilar is cheaper than the original product (the ‘innovator’ or ‘reference’ product) it is still very costly to bring one to market.  Biosimilar manufacturers must invest in clinical trials, manufacturing and post-approval safety monitoring programs, all of which are highly regulated and costly.  Sandoz is quoted as saying that it costs $2-3M to bring a generic to market vs. $75-250M to bring a biosimilar to market.

On the basis of cost and complexity, the biosimilar market has not taken off in the same way as the generics market.  It is now gathering momentum, however, with recent research confirming that, globally, the number of publicly-disclosed biosimilar development projects has increased over 40% in the last 12 months (Ref: PharmaTimes Online, May 01, 2014).

It is important to note that Biosimilars are not exact copies of the ‘biological reference medicinal product’ that has already been authorised i.e. not a ‘biogeneric’.  The active substance of these products is ‘similar’ to the reference product but the inactive ingredients, name, appearance and packaging can differ.

Please refer to our regulatory services pages for further information or contact us with your specific regulatory compliance requirements.