Biocon secures nod for its first biosimilar in US

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

Herceptin (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.

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

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

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

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

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

"Mylan anticipates potentially being the first company to offer a biosimilar 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 biosimilar to Herceptinin various markets globally," Mylan said in a statement.

Mylan CEO Heather Bresch said: "The approval of Ogivri represents a monumental achievement for Mylan 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, Mylan 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 biosimilar trastuzumab is indeed a crowning moment that puts us in an exclusive league of global biosimilar 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 biosimilar is also under review by regulatory authorities in Australia, Canada, Europe and several additional markets, the two companies said in a joint statement.

With inputs from PTI