Biosimilars are expected to become a significant piece of the generics business worldwide, and Alvogen is spending $250 million to build a facility in Iceland to develop and manufacture biosimilars.
In a way, the coming year isn't a big one for patent expirations. The total amount of sales jeopardized by patent expirations is $34 billion. That's more than the $28 billion this year, but far less than the $55 billion that hit in 2012. As for 2015? Forget about it. That year, products worth $66 billion will lose IP protection.
Plus, the drugs facing new competition won't all take a big hit in 2014. In fact, EvaluatePharma figures that the products newly open to generic competition will only lose $13 billion off their previous totals.
But if you're one of the companies looking at sudden exposure to would-be copycats, 2014 might be a very big year indeed. Check out the report >>
The Hatch-Waxman Act shook up the generic drugs business in 1984, and almost 30 years later, it's safe to say the law had its desired effect. About 84% of the 4 billion prescriptions written each year are for generic drugs, saving patients and government programs billions of dollars a year. In other words, generic drugs are big business. And with a slew of blockbuster brands now off patent, it's a big business with growing pains.
As companies bulked up to take on copies of the world's best-selling drugs, a wave of mergers has swept the industry. Many credit Actavis CEO Paul Bisaro with starting that trend; then the Watson CEO, his 2012 takeover of Actavis sent a clear message of "go big or go home" reverberating throughout the generics business. Actavis hasn't stopped scouting for deals, and many of its peers have followed suit.
Peruse the Top 10 to find out how these trends and market forces are shaping the industry's biggest players--and vice versa. Read the report >>
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The industry has been talking about, and slowly working toward, track-and-trace for many years. Now Pharma faces real deadlines that require action.
GlaxoSmithKline, which is already investing £500 million in new manufacturing facilities in its U.K. home, will spend £200 million ($330 million) more to upgrade plants and build a technology center. The company says the center will be all about new manufacturing and supply-chain technologies.
Merck KGaA last year closed manufacturing facilities as part of a major restructuring to cut costs. This year it is planning to build them to serve areas that it has decided have the greatest potential as well as expected growth in emerging markets.
Cardinal and CVS Caremark said they will create a 50/50 partnership to source generic drugs, which they claim will make them the largest generic drug dealers in the U.S. The two already do business but intend to kick off their new arrangement July 1.
Western drugmakers aren't the only ones building new plants in China. Taiwan's ScinoPharm has just finished up a $113 million facility to make active pharmaceutical ingredients for China, as well as for export to the U.S. and Europe.
When Congress boosted the FDA budget last year to station inspectors in other countries like China, where weak oversight has allowed tainted drug ingredients (and pet treats) into the U.S., China blocked visas for the new regulators. Now, with some intervention from the vice president of the United States, the logjam has been broken.
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It will allow doctors to spot patients who will benefit from those treatments.
It turns out that the FDA's new rule requiring unique device IDs (UDI) for high-risk medical devices was only half the battle. Regulators must hash out how that data will be submitted to a national database, and the back-and-forth between industry and the FDA over draft guidance designed to govern that process continues in full force.