Tag:
biosimilars
Latest Headlines
Latest Headlines
User fee legislation promises better access, speedier reviews at FDA
Bipartisanship is a rare sight in Congress these days, but a top tier of politicos in Washington D.C. says they've managed to hit the sweet spot with new user fee legislation being taken up by the Senate this week.
Amgen pushes agenda for biosimilars on the FDA
The Thousand Oaks, CA-base drugmaker is one of 30 organizations on the docket today for the FDA's informal stakeholder meeting to discuss regulation of biosimilars.
Abbott tries to throw up roadblock to Humira biosim
While Pfizer was reporting a 71% drop in U.S. Lipitor sales and plotting its next spin-off move, Abbott Laboratories was working to shore up its own breakup plans by protecting its pharma unit's lead drug.
PRA snags Amgen's PhIII biosimilars contract
The contracting coup comes four months after Amgen tied up with Watson on an ambitious pact to develop biosimilars of some leading cancer therapies.
Amgen VP warns FDA about quashing manufacturing innovation of biosimilars
Biosimilars have to be, well, similar, but having to keep that relationship too tight over the long haul could keep companies from manufacturing innovation, Paul Eisenberg worries.
Biopharma giants call on FDA to demand tough standards for biosimilars
Some of their greatest concerns reflected some clear anxieties about the eventual arrival of cheaper competition.
UPDATED: Crucell and Royal DSM pull the plug on biosimilar JV
A joint venture marrying the protein and antibody development technology of Crucell with the manufacturing knowhow of Royal DSM has collapsed.
Samsung says its manufacturing 'DNA' will provide big biosimilar savings
Mention South Korea's prowess in manufacturing and you might think of cheap cars or inexpensive electronics. How about biosimilars?
Samsung plans ambitious rollout of biosims at deep discounts
Samsung BioLogics is moving fast with some ambitious plans to start marketing biosmilars at a deep discount while striking more development deals.
UPDATED:Pfizer's marketing pact with Biocon falls apart
Pfizer ( $PFE ) and Biocon have gone their separate ways. The two companies had planned to jointly market Biocon's biosimilar diabetes drugs, but now they've chosen to go it alone. Pfizer will pursue an independent diabetes strategy, while Biocon will seek new marketing partners to take its products to other emerging markets, the U.S. and Europe.
