The Biosimilars Game: A market research report from BioWorld

January 25, 2013 9:11 AM

The quiet but growing flood of biosimilars – new versions of existing biopharmaceutical drugs – promises to reduce the overall costs of delivering highly effective biotechnology-based medicines, but it’s also a game changer for the entire drug development industry akin to the impact generics have had on traditional pharmaceuticals.

BioWorld – the industry’s news service focused on the development of biologics for more than two decades – has identified and profiled 139 key biosimilar developers with >276 biosimilars in their pipelines as well as 25 already approved, according to The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies.

“The emergence of this new drug development sub-industry translates into opportunities for patient access to very expensive but effective biotech-based therapeutics,” said BioWorld’s Executive Editor Lynn Yoffee . “But the development of biosimilars brings myriad questions related to drug efficacy – since they are not exact duplicates, just similar – as well as quality, safety and interchangeability with originator products. Perhaps the most complex issue at hand is the lack of global regulatory harmonization.”

In the new BioWorld Data report, biosimilars expert and Washington Editor Mari Serebrov provides:

  • In-depth analyses of biosimilar rules and activity in both emerging and regulated markets (15 countries/regions)
  • R&D cost comparisons
  • Data to spot the Big Hitters, including likely targets identified by the FDA, targeted MAbs and other biologics
  • Deal terms for 80 key biosimilar alliances

“Biologics makers need to rethink brand strategies because attempts at product hopping [which delayed generic competition for small-molecule drugs] may not work when biosimilars are available,” said Serebrov, author of the new BioWorld Data report.

“As the U.S. continues to wait for its first biosimilar to step up to the plate, global players are already betting on follow-on biologics to be one of the biggest hits in town,” Serebrov said. “To earn that star status though, biosimilars will have to show payers the money pretty quickly by delivering the power of biologics at a price economically strapped countries can afford.”

 

Source: BioWorld press release

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