Celltrion prematurely ended a Phase III trial for a biosimilar version of Roche's ($RHHBY) big seller Rituxan, but the South Korea-based biotech has plans to revive late-stage development of its copycat candidate in the second half of 2013, BioPharm Insight reported.
Roche faces one less potential copycat competitor to its blockbuster Rituxan franchise. The South Korea-based biotech Celltrion has nixed late-stage development of a biosimilar version of Rituxan, which is expected to face knockoff rivals first in Europe and then in the U.S. in the coming years.
Late last year Lonza and Teva sent a chill down the backs of an emerging group of developers working on biosimilars--those follow-on therapies that are expected to take the price of aging biologics down a peg or two as they lose patent protection.
With the first knockoffs of biotech drugs in the U.S. expected in the coming years, providers of the novel biologics such as Amgen and Genentech have pushed for state legislation that makes doctors and pharmacies clear hurdles before approved biosimilars are used in place of the originals.
For the past 20 years Express Scripts has been crunching the numbers on the ever rising amount of money Americans spend on drugs. But last year, the analysts say, the country hit a critical watershed as the amount spent on traditional drugs--the pills used for a host of common maladies--slid a bit while specialty drug spending surged 18.4% on the arrival of complex new therapeutics which have captured the attention of drug developers around the globe.
Grappling with major government budget cuts, the FDA is seeking remedies to preserve programs of vital interest to pharma and device companies. Now that sequestration has arrived today, power brokers in the White House and Congress could hold the keys to keeping the agency on track.
The news on the biosimilar R&D front has been all bad in recent months--at least for the biggest players in the business. Merck, Teva and Samsung have all experienced severe setbacks, scrapping follow-on programs for some of the biggest biologic targets now on the market.
Just two months after Merck dropped out of a snake-bit biosimilar development program for Enbrel, the pharma giant--which has experienced a number of setbacks in the field--has stepped back up with a new, high-profile partnership, teaming up with a new venture formed by the South Korean conglomerate Samsung and Biogen Idec.
The two partners are keeping the specific terms under wrap, but Mylan agreed to share the development costs of the three programs in exchange for commercialization rights in the critical European and U.S. markets.
Under the provocative headline "Game Poacher or Gamekeeper – Big Pharma's Stance on Biosimilars", Forbes contributor Simon King delineates the multi-pronged strategy of Amgen in the biosimilars game.