It was revealed today that Mylan has filed suit at the Washington District Court in an effort to get the FDA to withdraw Ranbaxy’s first-to-file (FTF) status for its generic version of Pfizer’s blockbuster anti-cholesterol drug, Lipitor (atorvastatin), and hence to rescind Ranbaxy’s 180...
Bioton and Actavis get closer to a deal on insulin
Bioton announced on March 7th that it had signed a Term Sheet with Actavis covering the two companies’ planned co-operation to develop Bioton’s portfolio of insulins, which includes insulin analogues. According to the press release, the two companies will set up a JV that...
Spanish market data for 2010 shows the big getting bigger
According to IMS data published in the Spanish trade paper El Global, the retail generics market in Spain grew by 15% in 2010 to reach a total value of just over €1bn. Net of discounts, we believe that the figure is closer to €800m...
Valeant goes back to its roots as it buys PharmaSwiss
Valeant announced today that is paying €350m (plus a possible further €30m) to acquire PharmaSwiss, a privately-owned company based in Zug. According to Valeant’s CEO, J Michael Pearson, PharmaSwiss is a ‘generics and OTC’ player operating in 19 countries and with a broad portfolio...
Squawks from Turkey: EastPharma issues a profit warning
EastPharma yesterday issued a profit warning, citing the recent increase in the mandatory discount that generic companies have to pay to the state health insurance fund. This rebate was hiked from 11% to 20.5% on December 18th last year and according to EastPharma, it...
Sandoz starts clinicals on biosimilar Rituxan – is the field already getting crowded?
In Europe, guidelines for the development of monoclonal biosimilars have been released for consultation and are expected to be finalised this year, providing clarity to manufacturers. In the US, there are currently no guidelines and the FDA is still mulling over the input that...