Robert Wessman, the Icelandic entrepreneur who built Actavis into a generics powerhouse and then sold out, has decided get into the biosimilars business. He has talked his home country into helping finance his plans.
Pfizer has always been proud of its design of Viagra, which has become known worldwide for its blue color and diamond shape. It thinks enough of it that it is fighting a pitched legal battle in Korea with drugmaker Hanmi Pharmaceutical over the shape of Hanmi's generic, which has grabbed nearly half the market there.
Mylan said today that it and Indian biologics partner Biocon have nabbed the first approval in India and will have a biosimilar of Herceptin (trastuzumab) ready to roll out early next year.
New pay-for-delay lawsuits are popping up around the country. Endo Pharma and Actavis have been named, as has AstraZeneca, Teva, Ranbaxy and Dr. Reddy's. And with the U.S. Supreme Court having defined its position this year, the pay-for-delay legal issue is being litigated under a whole new set of rules.
In the drug business, market exclusivity is king. Every branded business model is built on it. But what happens if your brand doesn't have exclusive market access? If you're Sanofi, preparing to launch over-the-counter Nasacort, you sue the FDA.
GlaxoSmithKline's Advair is hard to copy. Some companies have given up on generic Advair, while others have shied away altogether despite the substantial sales up for grabs. But what if generics makers had some help--and an expedited review process--from the FDA?
Mylan CEO Heather Bresch is looking forward to next year. After having red-hot earnings reports last year, the more lackluster results in 2013 have been a disappointment. The company reported a 25% drop in net profit and a 2% falloff in sales for its third quarter. But Bresch promises the generic drugmaker will return to form in 2014, and analysts are taking her at her word.
Pfizer's third-quarter results perfectly capture the forces shaping Big Pharma these days. Patent losses linger, with hundreds of millions lost to generic competition old and new. But Pfizer had growth in emerging markets and cancer sales to help stanch the flow, so overall sales only shrank by 2% to $12.6 billion. But shrink they did, and so did Pfizer's expectations for the full year.
Today, Novartis had the pleasure of hiking its 2013 forecast for the second time this year. And once again, it has Diovan to thank--or, to put a finer point on it, Novartis has Ranbaxy Laboratories to thank. The ongoing bumbling at the Indian generics maker means there's still no copycat version of Diovan to drain away sales of the blockbuster blood-pressure drug.
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.