The Mag

Biosimilars: A crippling lack of information

If you believe Murray Aitken, deficit-­ridden healthcare systems across the globe can save a lot of money through the use of the latest generation of biosimilars. He estimates that payors in the US and five major EU markets can cut costs by US$49bn over the next five years if the copy­cat meds are able to displace expensive bio­tech blockbusters losing patent protection by 2020. Aitkens is the Executive Director of the IMS Institute for Healthcare Informatics, and the author of the brand new report “Delivering on the Potential of Bio­similar Medicines”. 

It’s easy to understand what makes bio­­similars more cost-effective: bio­similar producers don’t have to submit a full dossier for market approval. But because biosimilars are manufactured with different cell lines than those used in the original, they do have to convincingly demonstrate comparability before receiving authorisation in their major target markets – the US and the EU. The IMS calculation is based on the assumption that lower development costs for bio­similars will translate into a price reduction per treatment day of around 20%. If that estimate proves conservative and prices drop by 30%, says the study, then healthcare systems could even save up to €74bn by 2020, changing the landscape by giving many more patients access to modern treatments with therapeutic proteins or monoclonal antibodies. Aitken stresses, however, that “not all markets are ready to fully benefit from the imminent surge of bio­similar molecules.”

Since the EU approval of the first bio­similar Omnitrope (Sandoz) a decade ago, the EU market has been slow to adopt biosimilar growth hormones such as somatropins and erythropoietins (EPOs), sexual hormones like follitropin alfa, or cytokines like filgrastims. Following the launches of biosimilar EPOs or filgastrims in Europe, prices fell between 14–59% locally (without rebates). However, market penetration by biosimilars couldn’t be simply linked to price reductions.