The Burrill Report


Teva Pharmaceutical and Lonza Group says they're reevaluating their joint venture to develop, manufacture, and market a portfolio of biosimilars.

More than four years after launching a partnership that the companies heralded as possessing “significant opportunities and benefits” for each other, they now see “significant regulatory uncertainty in the biosimilars arena” and circumstances that call for taking a “measured approach” before making further long-term investment decisions.

“The potential to develop, manufacture and market affordable, efficacious and safe biosimilars remains an area of significant opportunity for both Teva and Lonza,” the companies said in a joint statement. Indeed, biologics losing patent protection over the next six years registered annual sales of $47 billion in 2012, according to Bloomberg Industries. Companies from Boehringer Ingelheim to Samsung are working to develop new relatively low-cost biosimilar competitors to those medicines.

So far, Teva’s U.S. unit Sicor Biotech has sought and gained approval from the U.S. Food and Drug Administration for Tbo-filgrastim, a drug that is marketed as a biosimilar in Europe. But in the United States, Tbo-filgrastim was approved in an original biologics license application, not as a biosimilar to Amgen’s Neupogen (filgrastim), a product that contains “a related drug substance,” said the FDA. And Teva has had less luck creating a biosimilar version of Roche's Rituxan, announcing in October 2012 that it would quit studies of its experimental version of the drug.

But while the companies are reconsidering their options, they have not yet given up on the project. “Both as partners and individual companies, Teva and Lonza are focused on finding the best routes to realizing the benefits that safe biosimilars of certain biologic pharmaceuticals will bring to the healthcare community,” they said.




April 05, 2013
http://www.burrillreport.com/article-teva_and_lonza_review_biosimilars_joint_venture.html