Biocon Mylan win second Biosimilar drug approval within 6 months from US FDA

Overview

• Post By : Khushboo Sharma


• Source: Economic Times


• Date: 06 Jun,2018

Little over six months from the launching of their first biosimilar drug, Biocon-Mylan got another approval for their second biosimilar drug on Tuesday from US Food and Drug Administration. 

The second biosimilar drug which is pegfilgrastim, is a drug used to increase the white blood count of cancer patient, Biocon and Mlyan said in a statement on Tuesday. This biosimilar drug is a replace of Fulphila developed by Amgen with a market size of $4 billion. 

Biosimilar is becoming a new class of affordable drugs that are replacing those with expired patents in the US. Basically, biosimilars are identical copies of highly complex biologic drugs, that are made through biotechnology and derived from natural resources or produced naturally.

“It takes time for people to understand and embrace biosimilars. I think there is a huge momentum, better than what we anticipated and expected,” Mylan CEO Rajiv Malik said in a telephonic interview to ET. .

Now, currently Mylan has the right to market and sell the drugs in the US,Europe and Canada.Malik said the company expects to play on the affordability factor of the drug. Innovator drugs can cost much more than traditional prescription drugs and high cost can prohibit access, Malik said.