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

By Gareth Macdonald contact

- 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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