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Biocon secures nod for its first biosimilar in US

A biosimilar is a copy of an innovator biologic drug and is made of living cells

Aneesh Phadnis  |  Mumbai 

Kiran Mazumdar-Shaw
Kiran Mazumdar-Shaw

has secured the regulatory approval to market a for anti-cancer in the US. This will boost the Indian major's development capabilities and enhance profitability.

(molecule name Trastuzumab) has been developed by Swiss drugmaker Roche and is used for treatment of breast cancer and metastatic stomach cancer. It had sales of around $ 2.6 billion in the US.

sells of in India and other emerging markets but the US Food and Administration's approval is a significant move for the Kiran Mazumdar-Shaw-led company, which has charted a different growth path from other Indian makers.

The has been developed jointly by and for the US market and will be sold under the brand name Ogivri. The launch date has not been disclosed yet. has exclusive commercial rights for the US but the two will share profit from sales.

A Reuters report quoted Barclays analyst Douglas Tsao saying the is not expected to be launched until 2019.

Biocon secures nod for its first biosimilar in US
A is a copy of an innovator biologic and is made of living cells. 

and Mylan's for Trastuzumab is the first  copy for this particular and only the second to be approved in the US after Sandoz's Zarxio (a copy of cancer Filgrastim) which got approval in 2015.

"anticipates potentially being the first company to offer a to Herceptin, as a result of Mylan’s ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year. This milestone secured a clear pathway to commercialize Mylan’s to Herceptinin various markets globally," said in a statement.

CEO Heather Bresch said: "The approval of Ogivri represents a monumental achievement for to increase patient access to biosimilars and deliver significant savings to the US healthcare system." As one of the nation’s leading suppliers of cancer medicines, is excited to add to its portfolio a product representing a new generation of targeted therapies that have radically changed the way the disease is treated, she said.

Kiran Mazumdar-Shaw,  chairman of Biocon, said: “The US FDA's approval for our trastuzumab is indeed a crowning moment that puts us in an exclusive league of global players. It strengthens our resolve to focus on developing affordable biologics that can make cancer care both more effective and more equitable around the world. It is an important milestone in our journey of developing advanced therapies that have the potential to benefit billions of patients."

The is also under review by regulatory authorities in Australia, Canada, Europe and several additional markets, the two said in a joint statement.

With inputs from PTI

First Published: Sat, December 02 2017. 22:24 IST
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