The United States Foods and Drug Administration (USFDA) Oncologic Drugs Advisory Committee (ODAC) has recommended an approval of a biosimilar Trastuzumab in the US. Trastuzumab is Biocon and Mylan's biosimilar. It is a biosimilar version of Herceptin used to treat breast cancer in the US market.
In an interview to CNBC-TV18, Kiran Mazumdar Shaw, CMD of Biocon talking about the above development said that, “We are very pleased that the ODAC unanimously endorsed and recommended our biosimilar trastuzumab on the grounds that it is highly biosimilar, it is safe. This is a big endorsement of Biocon and Mylan's biosimilar Trastuzumab.”
It has bought us one step closer to final approval by USFDA, she said, adding that there is hope of this much awaited approval coming on September 3, post which it will allow the company to market the lifesaving drug in the US market.
“September 3 is an approval date indicated by USFDA, at which time they have to basically ensure that rest of the activities that need to be done, compiled by the USFDA will be done and then they will give us the approval,” she added.
This will be the first biosimilar trastuzumab that the USFDA will approve.
The road ahead for trastuzumab is expected to be smooth, she said.
Mylan and Biocon are partners in this programme and Mylan has entered into an agreement with Roche in terms of the launch date of trastuzumab, which cannot be disclosed, she said.
Herceptin has a market size of USD 2.6 billion in the US and we hope to take a significant chunk of this, said Mazumdar Shaw. Moreover, market opportunity for trastuzumab in emerging markets (EMs) would be around USD one billion, she said.
The company will have significant profit share with Mylan for trastuzumab, she said.
For full interview, watch accompanying video...
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