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.
While the FDA continues its slow-motion release of new guidelines for producing biosimilars in the U.S., India's Cipla has stepped up with a knockoff of the rheumatoid arthritis blockbuster Enbrel, which it will sell in the subcontinent at a 30% discount.
Biosimilars are expected to significantly expand the biologics piece of the industry and companies headed along that pathway are intrigued by single-use, or disposable, technology they think can cut costs and provide flexibility.
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.
Did Roche do the right thing when it took a pass on biosimilars?
By Eric Palmer Ganesh Kaundinya, chief scientific officer at biologics and biosimilars developer Momenta Pharmaceuticals, doesn't mind a little regulatory uncertainty. For those responsible for mapping a manufacturing strategy for biosimilars, these uncertainties add to the pressure of an already complex and challenging endeavor. Read the report >> Brought to you by CMC Biologics
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.
Drugmakers paid a toll to build the FDA fast lane for drug approval, only to find it full of speed bumps created by the sequestration law that went into effect today.
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.