Mylan and Biocon Ltd. on June 5 announced that US Food and Drug Administration has approved Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon.

Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S. Mylan anticipates launching Fulphila in the coming weeks, according to a release on June 5, Mylan CEO Heather Bresch commented saying: “FDA’s approval of this product, as well as the agency’s continued focus on Biosimilars, mark crucial steps towards lowering treatment costs and providing alternative options for patients.

As a leading supplier of cancer medicines in the U.S, Mylan is committed to offering affordable and accessible solutions for patients with cancer at every step of their journey. Enhancing access to treatment has always been our top priority and what we’ll continue to deliver to the healthcare system in the U.S. and beyond.”

Mylan President Rajiv Malik said: “The approval of Fulphila, the first biosimilar to Neulasta, joins other recent examples such as the approval of Ogivri, the first biosimilar to Herceptin, in the growing portfolio of complex medicines that Mylan is making available for patients who need them."

Biocon CEO & Joint Managing Director, Dr. Arun Chandavarkar, said: “ It represents a further endorsement of the Biocon-Mylan partnership’s ability to successfully develop complex molecules to exacting quality and regulatory standards. This approval expands our oncology portfolio for the benefit of cancer patients and supports our mission to improve access to high quality, affordable biopharmaceuticals globally.”