Manufacturing facilities in India that are approved by Western regulators are a hot commodity, and that is what Bafna Pharmaceuticals has. The Indian drugmaker is for sale and is reportedly drawing interest from potential buyers, including Mylan as well as some Indian drugmakers.
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.
Generic drugmaker Mylan is recalling 73 lots and more than 480,000 bottles of the generic blood pressure medicine amlodipine besylate.
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.
Mylan's $1.6 billion deal to buy the sterile injectable business of Strides Arcolab gets all the attention, but the company has expanded in India with several other small acquisitions on top of the big deal for Agila Specialties.
The Hatch-Waxman Act shook up the generic drugs business in 1984, and almost 30 years later, it's safe to say the law had its desired effect. About 84% of the 4 billion prescriptions written each year are for generic drugs, saving patients and government programs billions of dollars a year. In other words, generic drugs are big business. And with a slew of blockbuster brands now off patent, it's a big business with growing pains.
India also has signed off on Mylan's deal to buy the injectable unit from Strides Arcolab. The company reportedly agreed there to maintain the production of certain drugs in India that Agila currently manufacturers.
In a warning letter, the FDA has chastised the management of an Agila Specialties plant in India that Mylan ($MYL) is buying from Strides Arcolab for using defective gloves in the aseptic processing area and then not taking the problems seriously enough.
India finally granted Mylan the go-ahead this week to complete the buyout of the sterile-injectables unit of Strides Arcolab. But in Vermont the big news is the much more modest expansion of Mylan's transdermal patch facility in St. Albans.
Mylan and Par Pharmaceutical have made it through FDA scrutiny of their generic versions of antidepressant Wellbutrin XL in a regulatory episode that has reignited debate over the quality of generics versus branded drugs.