The FDA released a batch of 54 draft product-specific guidances Thursday to help sponsors identify appropriate science-based methodologies and evidence for developing generic drugs. The batch includes 12 new draft guidances and six revised guidances for complex drug products, such as Gilead Sciences Inc.'s combination hepatitis C drug, Vosevi (sofosbuvir/velpatasvir/voxilaprevir). Fourteen of the drugs addressed in the guidances don't have generic competition. "With this new batch of guidance documents, we're not only providing recommendations for some new generic drugs, but the FDA is also modernizing some of its previously issued guidance to make sure they reflect the most efficient path for developing generics," FDA Commissioner Scott Gottlieb said. The guidances have a 60-day comment period.
Taking into account results from the latest tests on valsartan from Zhejiang Huahai Pharmaceutical Co., of Linhai, China, the EMA reiterated Thursday that the lifetime risk of cancer from valsartan drugs containing N nitrosodimethylamine (NDMA) is considered low. The agency estimated the risk to be one in 5,000 for an adult patient who had taken an affected valsartan drug at the highest dose (320 mg) every day from July 2012 through July 2018, when the alarm was first raised about the active pharmaceutical ingredient (API). The risk is lower for patients who took drugs with lower doses or for a shorter period. It also is lower for patients who took valsartan drugs containing API produced by Zhejiang Tianyu Pharmaceutical Co. Ltd., of Taizhou, China, which had smaller amounts of NDMA. Neither company is currently authorized to produce valsartan for the EU, and regulators are considering the findings from inspections at the companies' manufacturing sites. The EMA also is assessing the impact of a related substance, N nitrosodiethylamine (NDEA), which was detected in valsartan made by Zhejiang Huahai using its pre-2012 manufacturing process. NDEA and NDMA both belong to the class of nitrosamines and are classified as probable human carcinogens. The EMA said data on the levels of NDEA are limited.
In its ongoing efforts to familiarize doctors and patients with biosimilars, the EMA Thursday unveiled an animated video for patients that explains key facts about biosimilars and how the agency ensures that they are as safe and effective as the reference biologics. The video is available in Dutch, English, French, German, Italian, Polish, Portuguese and Spanish. The EMA also released new translations Thursday of its biosimilar guide for health care professionals. The guide, first published last year in English, provides comprehensive and easily understandable information on the science and the regulation underpinning biosimilars, according to the EMA.