The FDA has recently approved a biosimilair drug in the US. The approval of the drug will have far reaching consequences for the multibillion dollar biologic drug market. What exactly is a Biogenic drug and why is it in news today? The expensive biogenic drugs are all set to become cheaper as less costly alternatives with similar action are available.
Biologic drugs are not covered under the 1984 law that cleared the way for low-cost generic pharmaceuticals. Biogenic drugs are so complex and expensive and are made of living cells, blood or tissues and are difficult to be copied. However with advances in science it is possible to make biosimilair drugs and this will ultimately pave way for the reduction in prices of biologic drugs. The latest FDA approval has been given under the 2010 by Affordable Care Act provisions designed to cut the cost of biologic drugs to patients. FDA has approved a biosimilair drug to the Amgen’s Neupogen chemo recovery drug. Already the consumers are getting cheaper generic drugs and hope the same will one day happen to the biologic drug.
The change in policy by the FDA will strip companies like Amgen and other major biologic makers of billions in revenue because of the virtual monopoly which they enjoy in the US market. The situation is different in Europe where many companies are already selling successful biosimilar drugs. The latest drug which has been approved by FDA is named Zarxio and is produced by Sandoz, a division of Novartis.
What will companies like Amgen do when its monopoly is compromised? Well it can also make knockoffs of Biologic drugs made by other companies around the world and make up to its losses in revenue. In the end it is the consumer who will benefit, if the prices of the drugs come down.