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Jan 12, 2017 at 08:21 | Source: Moneycontrol.com
Bengaluru-based biopharmaceutical firm Biocon on Wednesday said US drug regulator has accepted its partners Mylans biologics license application (BLA) for the proposed biosimilar of breast cancer drug Trastuzumab through the 351(k) pathway.

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USFDA to review Biocon-Mylan's biosimilar drug for breast cancer
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koppik

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Biocon  

in the rest of the world. In the U.S., Mylan`s Biologics License Application (BLA) for proposed biosimilar trastuzumab is currently under review by FDA. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017. Mylan currently markets its trastuzumab products in 14

9.06 PM Mar 13th

koppik

Gold Member

11 Followers

Biocon  

Gives visibility with goal date under the Biosimilar User Fee Act (BsUFA) of September 03, 2017!

7.47 PM Jan 11th

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