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The U.S. Supreme Court has asked the solicitor general to consider if a lower court erred in mandating that Novartis wait six months after approval of a biosimilar before going to market. Read More
Even with an abundance of FDA work left undone with biosimilars, industry development activities seem unaffected, with many “extremely active” in that space, an agency official says. Read More
The second highest court in the land rejected Mylan’s requested rehearing in two patent lawsuits, leaving the company with few options for avoiding the cases. Read More
The patent dispute over Janssen’s Remicade continues to balloon, with the drugmaker suing GE Healthcare subsidiary HyClone Laboratories over the use of cell cultures to grow a biosimilar of the drug. Read More