As of July 17, FDA approved 25 new drugs, the whole number of approved drugs is expected to exceed 43 in 2012, which is the highest in the past 10 years. The total sales of new drugs approved in 2014 will exceed $20 billion after 5 years.

  However, we have not seen any big brand products in the new drugs. The largest product is Celgene's PDE4 inhibitor, Otezla, for the treatment of psoriatic arthritis, which is expected to reach $927 million in sales in the United States for five years.

  Even so, it is not easy. Some analysts questioned Otezla's relatively high prices and limited therapeutic benefits to patients. Since last year, Gilead’s hepatitis C drug Sovaldi came out, its sales forecast breaks record repeatly. The company's next step is to market the fixed dose combination of Sovaldi and ledipasvir, and then replace the current interferon and ribavirin for most genotype patients. Albert is not far behind, it has similar drugs, the combination of the two is expected to become a "blockbuster."

  At the same time, immune new drugs for tumors will also be coming: Merck's pembrolizumab is awaiting approval for melanoma treatment. The drug's rival is nivolumab from Bristol-Myers Squibb Company, which is expected to be available during the year. Bristol-Myers Squibb submitted a application for nivolumab for the treatment of non-small cell lung cancer in April this year and is expected to submit a listing application for treatment of melanoma in the third quarter.

  Last year, FDA approved 19 new drugs up to July, the progress of the drug approval is compliance with expectations in the remaining time. There were 35 small molecules and biological products in the whole year, the previously expection is 38.

  It is expected that the total sales of new drugs will be $21.8 billion after 5 years of listing, and the revenue forecast for drugs approved in 2013 will increase from $16.3 billion in last year to $24.5 billion.

  As new drugs approved this year, ledipasvir/Sovaldi combination and nivolumab are expected to reach $2 billion and $3.1 billion in 2019, respectively.

TAG: Chemical Reagents, Biomedicine