As the Generic Drug User Fee Amendments of 2012 (GDUFA) approaches the first anniversary of its enactment, the program has achieved a number of significant milestones. The program, designed to speed access to safe and effective generic drugs by supplementing federal funds with industry user fees, has: Made significant strides in reducing the backlog of … Continued

The antibody knockoffs are coming–gradually. Today the European Commission made healthcare history with its first approval of a biosimilar antibody–Inflectra (infliximab)–which was developed by Korea’s Celltrion and will be sold by generics powerhouse Hospira ($HSP). But the companies don’t expect to file for U.S. approval until 2015 as they wait for the FDA to finalize … Continued

The biosimilar market is a rapidly-growing segment of the pharmaceutical industry, but the US is still in the early stages of developing biosimilar regulation. In recent months, several US states have been contemplating passing bills on biosimilar drug use, and the California Assembly is thelatest to pass such a bill. The Californian legislation would require … Continued

You may want to think twice before taking any more generic copies of brand-name pharmaceutical drugs, thanks to a recent Supreme Court ruling that effectively eliminates manufacturer liability in injury cases resulting from negative side effects. In a 5-4 ruling, the Supreme Court recently overturned a $21 million judgment awarded to a New Hampshire woman … Continued

Washington, D.C. (June 13, 2013) Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO), today issued the following statement on the U.S. Supreme Court’s decision regarding Myriad Genetics’ patent claims on isolated DNA molecules: “The Supreme Court today summarily ruled that so-called cDNA remains eligible for patenting. cDNA is the commercially most important … Continued

Drugmakers generally get fair warning when generics target their drugs, giving them some time to prepare for the inevitable eating away of revenues. But Amgen ($AMGN) was delivered a nasty surprise about its superblockbuster Enbrel this week when a new study found that a cocktail of generics already on the market was as effective at … Continued