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U.S. FDA accepts Biologics License Application (BLA) for Mylan and Biocon’s proposed Biosimilar Tras pharmaasia
February 07, 2017
If approved, MYL-1401O has potential to be the first Biosimilar Trastuzumab in the U.S.
Biocon wins MYR 300 m contract for insulin from MoH, Malaysia financialexpress
January 26, 2017
Will supply rh-Insulin manufactured at its new facility in Malaysia to public sector hospitals and clinics through CCM Pharmaceuticals
Boehringer Ingelheim biosimilar candidate to Humira accepted for EMA and FDA regulatory review worldpharmanews
January 20, 2017
Boehringer Ingelheim announced that BI 695501, its adalimumab biosimilar candidate to Humira®*, has been accepted for regulatory review by the European Medicines Agency (EMA) and the U.S Food and Drug Administration (FDA).
Boehringer Ingelheim biosimilar candidate to Humira accepted for EMA and FDA regulatory review firstwordpharma
January 19, 2017
Boehringer Ingelheim announced today that BI 695501, its adalimumab biosimilar candidate to Humira®*, has been accepted for regulatory review by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
US Supreme Court agrees to hear Novartis' challenge of rule governing biosimilar launches firstwordpharma
January 16, 2017
The US Supreme Court on Friday agreed to hear Novartis' appeal seeking to overturn a law that requires companies to wait 180 days after obtaining FDA approval for a biosimilar drug before they can begin marketing the product.
FDA accepts BLA for Mylan and Biocon's proposed biosimilar trastuzumab cphi-online
January 13, 2017
If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the US.

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