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Regulatory News | 09 May 2017 | By Zachary Brennan
A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low.
The report looks at the six classes of medicines in which biosimilars are approved, including epoetin, granulocyte-colony stimulating factor, human growth hormone (HGH), anti-tumor necrosis factor (anti-TNF), fertility and insulin products.
With 28 biosimilar approvals, the EU is outpacing the US’s five biosimilar approvals, though the biosimilar approval pathway in the US was implemented more recently and some products have been approved in the EU as a biosimilar but as a biologic in the US.
“In classes with more than one biosimilar, there is a weak correlation between the number of biosimilar competitors and the change in price of the total market,” the report says, noting that savings can come even when there are not multiple biosimilars for the same reference product on the market.
“However, in the long term, it may be necessary to have multiple biosimilars in order to achieve the full effect of competition. This dynamic is very different to small molecule generics, but may differ by class, and may evolve as we see more competition in newer classes,” the report adds.
It also notes that in some therapeutic classes, such as anti-TNF and HGH, lowering the price of the reference product can limit the market penetration of the biosimilar.
But the report also highlights the first to market advantage, as the first biosimilar usually takes the highest biosimilar market share.
And for most classes observed in the report, there is a significant increase in consumption since biosimilar entry in countries which had low starting volumes.
“The experience so far with Biosimilars in Europe illustrates the heterogeneity between biosimilar products, therapy areas, and countries. There is not just one formula that will work to achieve the savings potential, but learnings can be taken from all areas,” the report adds.
The impact of biosimilar competition on price, volume and market share - update 2017
Tags: biosimilars, biologic competition, anti-TNF, HGH