Mylan said in a statement Ogivri is the first biosimilar in its collaboration with Biocon to get U.S. approval, and while it has kept quiet about its commercialisation plans some analysts have suggested it will start making revenues from the drug in 2019 - the year in which Roche's USA patent on Herceptin expires. Biosimilar drugs are identical copy of highly complex biologic drugs that claim to have the same efficacy as the innovator's version. Mylan and Biocon's biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India.
Scott Gottlieb, FDA Commissioner (MD, USA), concluded: "The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs".
The FDA's decision was based on data showing the structural and functional similarities between Ogivri and Herceptin, in addition to preclinical and clinical trial data showing similar safety and effectiveness.
"Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the US", Biocon said in a statement.
"The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the U.S. healthcare system", said Mylan's chief executive Mylan chief executive Heather Bresch.
Elton confirmed that he and his mother were still in touch as he said he had only seen her last Monday. No doubt John is grateful for the time he was able to spend with his mother before it was too late.
Friday, during one of the team's media availability sessions, Rivers expressed contrition for dressing down the court-side fan. With L.A. on its way to a 126-107 home loss to the Jazz last night, Austin Rivers confronted a courtside fan.
Edwards also offered up this gem as he paraphrased former Arizona State star Pat Tillman: "Football ignites my soul". The former New York Jets and Kansas City Chiefs head coach hadn't conducted a press conference in a while.
Bitcoin futures and other derivatives would make it easier for more investors and speculators to trade the new asset class. Due to its volatility, bitcoin futures will be subject to higher margin levels and intraday price limits, the CME said .
Title game history: The Big 12 championship game is back for the first time since 2010, before TCU joined the conference. The Sooners' spot in the top four would make it their second playoff berth since the format was introduced in 2014.
Mattis began his five-day tour of the Middle East - including Egypt, Jordan and Kuwait - and Islamabad Dec. 1. Saeed heads the UN-listed terrorist group Jamaat-ud-Dawa and has a $10 million U.S. bounty on his head.
This is very much a possibility, as it has been proven by Bryce Love and Stanford that Washington can be beaten on the ground. Penn State is 2-0 all-time against the Huskies with the win in the 1983 Aloha Bowl and a 21-7 win at Washington in 1921.
Ball told ESPN he hasn't decided where LiAngelo will play this season. "The plan is now to get Gelo ready for the NBA Draft". As you know, LiAngelo was indefinitely suspended from the team after he stole from several stores during a trip to China.
Saudi Arabia, accusing Iran of backing the rebels, intervened in Yemen on behalf of the government the following year. In a televised speech Monday, Houthi leader Abdel Malek al Houthi declared victory against Saleh.
Security Council meeting about the ongoing violence in Myanmar, against Rohingya Muslims on September 28, 2017 in New York City. The United States has made a decision to end participation in the UN process to develop a Global Compact on Migration (GCM).