Not so fast, Teva. The generics giant--which last week said it was set to roll out copies of Pfizer blockbuster Celebrex--now has to put those plans on hold, as per a U.S. appeals court ruling.
Bayer was dealt a crushing blow in its ongoing fight to block generic sales of its cancer powerhouse Nexavar in India, as the country's Supreme Court ruled that an Indian generics group had the right to sell a copycat version of the drug.
Biotech companies and biosimilars makers have been squabbling for years about the way the lower-cost copies will be prescribed and distributed. Brand makers wanted to raise hurdles to replacing their meds with biosimilar versions. But now, with biosimilars nearing their U.S. debut, the two sides have reached a compromise.
Look out, Pfizer--the generics are here. On Wednesday, Teva and Mylan both launched versions of the company's arthritis med Celebrex, meaning Pfizer is about to watch the sales decline of yet another blockbuster.
Indian drugmaker Zydus Cadila has launched a biosimilar of Humira in its home market--the first in a long line of in-development copies to threaten AbbVie's powerhouse med.
Last year, the U.S. Supreme Court slapped the industry with an unfavorable pay-for-delay verdict, ruling that consumers have the right to challenge brand-name drugmakers' patent settlements with generics companies. Now, in what could become a bellwether case for the industry, AstraZeneca scored a victory federal court as a jury found that the company's deal with Ranbaxy Laboratories to delay a generic launch of its heartburn med Nexium was not anticompetitive.
The biosimilar bonanza is underway, and Johnson & Johnson's rheumatoid arthritis drug Remicade is at the center of the copycat action. Boston-based biosimilar maker Epirus Biopharmaceuticals is rolling out a knockoff of the monoclonal antibody (mAb) in India with partner Ranbaxy Laboratories, a year after Hospira got its Remicade version approved in Europe.
Ranbaxy Laboratories has filed a federal lawsuit trying to reverse the FDA's decision to cancel its approvals to make generics of AstraZeneca's blockbuster Nexium and Roche's Valcyte.
After months of percolating discontent about generic drug price hikes, the U.S. Senate is hauling drugmakers to a hearing this week. But the real threat lies at the Department of Justice, which is likely considering criminal prosecution for price-fixing and other antitrust violations, Law.com reports.
The FDA's new due diligence on generic drugs now has one victim: Mallinckrodt, which makes a knockoff version of Johnson & Johnson's ADHD drug Concerta. The Dublin-based drugmaker says the FDA is questioning whether its generic actually measures up to the brand.