From what I read on some of the posted patent application descriptions leads me to believe that one of the FOB's being created by MNTA is ABBOTT's HUMIRA.
Law change allows cheaper generic versions of biotech drugs Loss of patents on pricey drugs such as Abbott's Humira will cut into company profits
In 2001, Abbott Laboratories spent nearly $7 billion on the biggest acquisition in the company's 123-year history, primarily to access one drug, Humira.
Since then, the North Chicago-based drug giant has raked in more than $24 billion in sales from Humira, a pricey medicine derived from human cells and used to treat a variety of autoimmune diseases. This year, Humira is forecast to have its biggest year ever, with some analysts projecting more than $7 billion in sales. [MNTA, at this price, is a STEAL!]
But the national health care law is intended to put the brakes on the profit bonanza from Humira, as well as many other biotechnology drugs, by opening up the sector to generic competition. That will make biotech drugs, also known as biologics, which are innovative treatments derived from living cells, affordable to more consumers.
Many patents on some top-selling biotech drugs will start to expire in the next few years. But when "biosimilars" or "biogenerics" will be available to U.S. consumers is unclear. The Food and Drug Administration is working on guidance on how the approval for this class of generic drugs will work.
"Biotech drugs are among the world's most expensive," said Dr. Sidney Wolfe, director of the health research group at Public Citizen, a consumer watchdog of the health care industry. "They have been good, but they have been expensive, so it is extraordinarily important to get biogenerics as quickly as possible."
wheeler said, they are working on follow on biologics much before lovenox ANDA was filed (hope i heard this right? or did he say approved?)
Say MNTA is working on Enbrel from 2008 Say FDA defines pathway by Jan 2012 Say MNTA files ANDA in Feb 2012 (not sure Enbrel would require some clinical trial - ofcouse that depends on how much sameness MNTA can demonstrate) Say FDA takes 18 months to review Enbrel ANDA Do you think it is realistic to see MNTA's Enbrel ANDA approval and launch before Jan 2014 ?
Some dates of 2016,2017 were bandied around in the conference call ...Can somebody put that in context ? Was CW saying the 1st bio-similar in the US could get approved/launched as early/as late as 2016?
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