"The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the USA healthcare system", said Mylan's chief executive Mylan chief executive Heather Bresch.
Star Wars Battlefront II Update Increases Credit Payouts
Immediate updates include the increase of end-of-round payouts, letting players take home more credits for a job well done. The mode initially drew criticism for severely limiting how much players could earn compared to those playing online.
Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). "This is especially important when it comes to diseases like cancer, that have a high cost burden for patients", Scott Gottlieb, FDA commissioner, said in an agency press release. "We're committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs".
Ogivri (trastuzumab-dkst) became the first biosimilar to Herceptin approved by the U.S. Food and Drug Administration (FDA) on December 1, and covers its use in all indications in the original treatment's label, including HER2-overexpressing breast cancer and metastatic stomach cancer.
"It will allow us to bring this important biosimilar - the first of its kind - to market in the USA, expanding cancer-patient access to more affordable treatment". Dr Arun Chandavarkar, 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.
Lindelof reflects on start to life at Man Utd
The Frenchman was sent-off towards the end of Saturday's 3-1 victory over Arsenal for a stamping challenge on Hector Bellerin. Selected for tomorrow, yes, for sure. "He is selected for tomorrow for sure - to start or be on the bench I can not answer".
In the USA, an estimated 250,000 new cases of female breast cancer and 28,000 new cases of stomach cancer are expected to be diagnosed in 2017 alone.
Annual sales of the Roche's cancer medicines - Rituxan, Herceptin and Avastin - top $21 billion, or more than half of its pharmaceuticals business, but are under threat as their biosimilar versions get approval.
Saleh's death unites Yemeni parties
The rebel alliance splintered last week, setting off heavy clashes between the Houthis and Saleh's forces. Yemen's rebel-controlled interior ministry on Monday announced the "killing" of former president Saleh.