subject: Global Pharmaceutical Memorabilia [print this page] In 2012, the European and American macroeconomy still in the doldrums. The Governments have cut medical expenses to control the budget deficit, and medical institutions are encouraged to use generics. But for the pharmaceutical genetic factory, the market space is getting smaller and smaller. In order to remain competition in face of the global economic recession, pharmaceutical companies laid off a large number of R & D and salesmen, and hope to achieve a continuous revenue growth through transactions. Compared with the hundreds of billions dollars in acquisitions several years ago, the global pharmaceutical industry M & A activity is relatively flat. Throughout the year, the biggest merger spends $ 7 billion acquisition of European competitors Actavis Watson Pharmaceuticals. Wall Street news is that the FDA approved 35 new drugs, which picks up the momentum of innovation in the pharmaceutical industry in 2012. This year, the U.S. drug shortages have eased, but due to the lack of FDAs regulation on dispensing business, it results in the outbreaks of meningitis spreading in 18 states of the United States, and about 1.4 million people have been affected. FDA issued biosimilar Guide. FDA finally issued 3 biosimilar R & D which is the long-awaited draft guidance of pharmaceutical industry. The FDA requires that biological drugs and the original drugs must have a high degree of equivalence, which need the verification in several ways, and also require biosimilar drug dealers provide the security monitoring report by long-term study. Comments: According to Datamonitor statistics, the global biosimilars market was only $ 243 million in 2010, but with the deadline of the patents in sales of $ 51 billion profited by 31 kinds of biological drugs. In 2015, the global biosimilars market will grow to $ 3.7 billion. This is a promising market, which attracts multinational giants to step in.
To make the biosimilars enter the United States, the FDA takes an innovative approach to approve. The guide is designed to help the industry develop biosimilars based on the existing biological products. According to the assessment of the U.S. Congress, over the next decade, biosimilars will save the U.S. $ 25 billion pharmaceutical expenditure. However, biological imitation pharmaceutical companies must overcome the challenges of technology, capital and markets. The complexity of the biological agents is far more than that of the general chemical drugs. Because of security considerations, it led to the delay of the announcement of the biosimilars listing application guide. The future biosimilar business will not focus on the price, but will pay more attention to improve the biological similarity of bio-generics and the original drug research.
