MSD set to take on Pfizer in Oz after Samsung Bioepis' biosimilar Enbrel is approved

By Gareth Macdonald

- Last updated on GMT

Australia OK's Samsung Bioepis' Enbrel biosimilar
Australia OK's Samsung Bioepis' Enbrel biosimilar

Related tags Samsung bioepis Etanercept

Australian regulators have approved Samsung Bioepis’ Enbrel (etanercept) biosimilar in both auto-injector and prefilled syringe formats.

The product – called Brenzys – has been cleared to treat the same range of autoimmune disorders as the originator product according to an announcement posted on the Therapeutic Goods Administration’s (TGA) website on July 22​.

The document lists consulting and regulatory services firm ERA Consulting (Australia) Pty Ltd as the sponsor.

However, the drug will be sold in Australia by MSD – the name for Merck & Co outside the US and Canada – according to Samsung.

Brenzys – also known as SB4 - was approved in South Korea last September​ and was launched by MSD the following December.

The drug has also been approved​ in Europe where it us sold as Benepali.

Supplies of the drug for the European market are made by Biogen – which co-owns Samsung Bioepis with joint-venture partner Samsung – at a facility in Hillerod, Denmark.

Amgen owns Enbrel, which acquired it with the acquisition of Immunex in 2002.

In Australia the product is sold by Pfizer​, which took on the role when it bought Amgen’s previous marketing partner Wyeth in 2009.

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