On June 24-27, 2013, the Drug Information Association ("DIA") held its 49th Annual Meeting at the Boston Convention and Exhibition Center. Highlights of the first day are provided here. DIA's Annual Meeting continued with a variety of other presentations on topics such as personalized medicine, orphan drugs, developing treatments for Alzheimer's Disease, biosimilars, and more. Some of topics covered are described below.
One of the themes of the conference was orphan drugs and personalized medicine. To those ends, several speakers advocated for FDA guidance on designing clinical trials for orphan drugs, going from a handful of patients to approval, as well as designing clinical trials for personalized therapies.
While there are biosimilars in emerging markets, it remains unclear how useful the information would be for product development in the United States. First, many of the biosimilars in emerging markets were approved prior to regulatory rules or guidance in those markets. Second, most of the biosimilar manufacturers in emerging markets have since designed or are working on modifications to their biosimilars, in particular their clinical development plans, to meet the requirements of FDA, the European Medicines Agency ("EMA"), and similar industrialized, regulatory authorities. To the extent biosimilars marketed in emerging countries have been analyzed, there were potency variations in tested epoetins from 48-163% in mice, many had high amount of aggregates, and many failed to meet EMA specifications. But in emerging markets, the innovator counterpart to biosimilars may not be available for comparison, leading to higher patient acceptance and government support, e.g., China has had biosimilars for more than 20 years. In China, however, biosimilars were regulated similar to small molecules until 2007, when China established a China FDA in 2007, which is currently creating a defined pathway for biosimilars under the new regime. Brazil, Mexico, Argentina, India, and Korea also have marketed biosimilar products with varying degrees of regulation and standardization.