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Biocon, Mylan Gets US Approval for Ogivri- Biosimilar for Trastuzumab

US Food and Drugs Administration (USFDA) have provided approval to Biocon and Mylan for its biosimilar Herceptin or trastuzumab, Ogivri. Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-over-expressing breast cancer and metastatic stomach cancer.

Ogivri is first in many categories including first FDA-approved biosimilar to Herceptin, first biosimilar from Mylan and Biocon joint portfolio approved in US. Also, Mylan will hold exclusive license for biosimilar in addition to holding global licenses for trastuzumab. This milestone slated a clear pathway to commercialize Mylan’s biosimilar to Herceptin in various markets globally.

With its launch, patient access to biosimilar will increase and lead to significant savings to the US healthcare system. It will allow cancer patients to gain access to more affordable treatment. Ogivri, will hold an important positions in Mylan’s product portfolio and will allow patient’s access to important medicines.

Dr ArunChandavarkar, CEO & Joint MD, Biocon, added that the approval represents a landmark achievement for the Biocon-Mylan collaboration and is an important endorsement of our development and manufacturing capabilities in the area of monoclonal antibodies.

Mylan and Biocon's biosimilar for Herceptin also is under review in Australia, Canada, Europe and several additional markets. It is approved in 19 countries, including India.

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