Generics make up about 80% of the drugs U.S. consumers use, but there has long been questions about whether some of them work as well as the products they mimic. Now the FDA is finding out.
An EU drug-review committee recommended Teva Pharmaceutical Industries' knockoff version of the AstraZeneca respiratory med Symbicort on Friday. With key patents already expired, Teva's DuoResp Spiromax could soon put AstraZeneca's brand under siege.
The antitrust crackdown in pharma has moved to Australia. Once again, Pfizer finds itself in the middle of a legal fight over its efforts to hang onto Lipitor sales after the drug went off patent and faced competition from cheaper generics.
Last year, Roche appeared to throw in the towel on its breast cancer drug Herceptin in India when it said it would not defend the patent there. But it has come back out swinging with a court action that has messed with this week's launch of a biosimilar from Mylan.
France wants to save money on drugs. That's not unusual. It's proposing new plans to pump up use of generics. That's not unusual either. What's less common is that Bristol-Myers Squibb is threatening layoffs at two French factories in retaliation.
2014 looks to be another year of transition for Novartis. It now expects the long-delayed U.S. release of a generic of its blockbuster Diovan to happen in the second quarter and by summer's end hopes to have completed the strategic review that will decide the fate of several of its operating units.
First, South Africa proposed patent-law changes that would help foster generic drugs. Then, Big Pharma and its smaller colleagues in the country's pharma association hatched a counter-offensive: a $600,000 lobbying campaign against the measure. Now, Novo Nordisk has quit that group, the Innovative Pharmaceutical Association of South Africa (Ipasa), in protest.
Generics maker Par Pharmaceutical inked a deal to pay $490 million for JHP Pharmaceuticals, a specialty pharma company owned by Warburg Pincus. Par will gain a portfolio of branded and generic injectable drugs, which are hot commodities these days.
South Africa's Minister of Health, Aaron Motsoaledi, lashed out on Friday at a report that Big Pharma is funding a PR campaign aimed at opposing new patent provisions favoring generic drugs, calling it "a conspiracy of satanic magnitude" that would lead to "genocide."
Novartis' blockbuster Diovan has enjoyed nearly 18 months of sales unscathed by generics since its patent expired in September 2012, as regulatory entanglements have kept Ranbaxy Laboratories from producing its copycat version. Now the Indian drugmaker has a plan to finally get it to market and claim its 6 months of exclusivity.