Biologics on the Rise

In the following, I’d like to turn into a topic important in the biotechnology history, the modern biotechnology history. Because of the emergency or emergence of the product and the prevalent use of the product. Let’s look at this slide. The y-axis is the number of products approved by the US FDA. And the x-axis is year from 1993 to 2004. And as you can tell for the small molecules. The numbers continued to decline. And for the biologicals or biologics the number continued to rise. Until 2002, the two lines actually cross There after the biologics continued to increase and the small molecule continued decrease. Of course, now the two lines crossed again. And this is the product approval between 2014 and 2015.

And the biologics is about 30 percent or 1/3 of all product approved. Although it said smaller number compared with small molecules but because the unit price for the biologics is very high, so the total sell is still much greater with the biologics compared with the small molecules. And this slide shows the global market for biologics as of 2010. There are 3 major categories biologics, protein antibody, and the vaccine. And these are the number product launched in 2010. New and old by the way. And worldwide sales in US dollar 40 billion to 16 billion for vaccine And that number of blockbusters. There are quite a few blockbuster of biologics.

Blockbuster is defined as having annual sell, worldwide annual sale of greater than 1 billion. And you can tell that blockbusters far exceed the small molecules. Because the unit price of the biologics. This slide shows the world annual sale of the top five. And among the top five two are for cancer. Three and four are rheumatoid arthritis. Year of their were approved. And the annual sales, again, 2010, seven, eight and nine billion dollars and a lot of money. Let’s look at the US market for biologics. Aranesp, one billing. Epogen, five billion. And, in fact, Aranesp is a prolonged form or extended form of Epogen. So two together make up six billion dollars and that’s in 2010.

The number, of course, it’s much bigger now. This is the top ten. Let’s look at the top eight, again, worldwide. Look at the patent protection. Patent protection usually lasts for 20 years and at 27 years for offer drop. Exclusivity refers to the data exclusivity, that is the other manufacturers Manufacturers cannot use their data for application for new drug applications. And whether is patent protection or exclusivity, data exclusivity, All of the biologics expired by 2018. So you can imagine all the generic companies are set in motion to produce the so-called biosimilar biologics.

Teva, the largest healthcare company in Israel Ranbaxy in India, Apotex in Canada, Santoz in Europe, and even Merck and Pfizer are getting into action by teaming up with other biologics company. And the key biosimilar products includes insulin, human growth factor, Epoetin, CSF, colony-stimulating factors, Interferons and Interleukins and the tissue necrosis factors.