Pegfilgrastim approval, another boost to Biocon's Biosimilar dreams

Biocon and Mylan expect to launch this drug in the coming weeks. Pegfilgrastim is a $4.2bn drug in the US.

Jun 05, 2018 08:06 IST India Infoline News Service

Biocon Limited
As per our expectations, USFDA has approved Biocon and Mylan’s Pegfilgrastim Biosimilar branded as Fulphila. This is a biosimilar to Amgen’s brand Neulasta, which had US sales of $4.2bn for the 12 months ending March 31, 2018, according to IQVIA. This is a big boost to Biocon's biosimlar dreams and its plan to reach $1bn biologics sales in 2025. (read - Biocon - $1bn biologics sales in 2025 means Rs1 lakh crore market cap)

Fulphila is expected to be the first biosimilar Pegfilgrastim available in the US to help patients with nonmyeloid cancers to reduce the risk of infection following myelosuppressive chemotherapy. Fulphila is the second FDA-approved biosimilar through the Mylan-Biocon collaboration, the first was biosimilar to Trastuzumab which was approved last year.

Biocon/Mylan expect to launch Pegfilgrastim in the coming weeks.

Approval to Pegfilgrastim represents that Biocon/Mylan joint collaboration is fructifying and the positive thrust to the partnership and also to the confidence of the shareholders.

Biocon/Mylan are exclusive partners on a broad portfolio of total 11 biosimilar and insulin products. Mylan has exclusive commercialization rights for the product in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

This is a positive announcement on the counter and Biocon should continue to ascend going ahead. We have a buy on the stock, read IIFL view on Biocon.

Related Story

Open Free Demat Account (Rs699)