It's been a long battle since a court upturned Teva's Copaxone patent in July 2013, but a Supreme Court fight, several petitions and a regulatory journey later, Copaxone generics are here.
Otsuka has already sued the FDA to block generic versions of the blockbuster antipsychotic Abilify, claiming that its orphan drug exclusivity on one indication should preclude copycat meds entirely.
Hefty increases in drug spending have lawmakers all riled up, and a new voice is joining the growing chorus of discontent. The Department of Health and Human Services is weighing in on the issue, planning to investigate the cause of soaring generic drug prices amid congressional pushback.
Generics player Natco Pharma has already made plenty of waves in the Indian pharma market with cheaper versions of blockbuster meds, playing by a patent challenge strategy that's ignited the ire of more than one Big Pharma company. Now, as it awaits U.S. approval for its knockoff of Teva's Copaxone, it's eyeing up other products to copy, too.
Since Mylan went public on Wednesday with a $205-per-share buyout offer for Ireland's Perrigo, analysts have been weighing the pros and cons of a tie-up between the two generics makers. But there's one thing at least a few of them agree on: The $29 billion bid has to be a response to other M&A action going on behind the scenes.
In a year when several of his peers won big payoffs for one extraordinary reason or another, Amgen CEO Robert Bradway earned just about as much as he had the previous year, give or take a few hundred thousand. Small comfort--though some comfort, perhaps--to the thousands of employees facing job cuts as Amgen prepares for biosimilar competition to its top-selling meds.
It's not just that Teva doesn't want the FDA to approve generics of its MS star, Copaxone. It really, really, really does not want the FDA to approve them, and it's filed yet another citizen's petition to the agency with a crop of reasons why it shouldn't.
With Sun Pharmaceutical's $4 billion buyout of Ranbaxy Laboratories all but wrapped up, the combined company has plenty on its plate: get plants banned by the FDA in order, get more products approved and to the market and find $250 million in savings with minimal layoffs.
Colorado's house of representatives passed a bill allowing pharmacists to substitute biosimilar versions of biotech drugs, even when the brands are prescribed by name. The approach would almost mirror the substitutions allowed with standard generic meds, except for the fact that pharmacists would be required to notify doctors about the change.
It's more bad news for Eli Lilly's Alimta in Europe. After losing a patent fight last year with Actavis in England, the Indianapolis drugmaker has now lost another in Germany, paving the way for knockoff versions of its top drug there.