USFDA Clears Cancer Drug by Biocon-Mylan


Biocon (an Indian biopharmaceutical company) and its partner Mylan N.V (An American global generic and specialty pharmaceuticals company) have received an approval for their first biosimilar of cancer medicine pegfilgrastim (Fulphila) from the U.S. drug regulator, USFDA (US Food and Drug Administration) to sell in the American market.

Pegfilgrastim is a biosimilar version of Amgen’s Neulasta used to stimulate the level of neutrophils, a type of WBCs that gets damaged in cancer patients undergoing chemotherapy. According to data from pharma and healthcare consultancy firm IQVIA, Neulasta had U.S. sales of $4.2 billion for the 12 months ending March 31, 2018.

Their drug is expected to be the first biosimilar of pegfilgrastim available in the U.S. market and will be sold under the brand name Fulphila to help patients with non-myeloid cancer reduce the risk of infection following myelo-suppressive chemotherapy. Pegfilgrastim is sold under the brand name Neulasta in the U.S.

After Trastuzumab in late 2017, Fulphila is the second biosimilar developed by Biocon to get an approval from USFDA. Mylan anticipates Fulphila launch in the coming weeks, giving cancer patients in the US the first alternative and affordable treatment option to branded Pegfilgrastim. The company had recently reiterated its second half 2018 launch guidance for pegfilgrastim.

As Fulphila is the first FDA-approved biosimilar Pegfilgrastim, it will have a first-mover advantage in the US and is expected to contribute to Biocon’s revenue in FY19, as well as to its profits through a profit-share arrangement with Mylan. 

Arun Chandavarkar, Biocon CEO and Joint Managing Director said, “It’s a moment of great pride to be the first to receive approval for a biosimilar pegfilgrastim by the USFDA,” and further added “This important milestone comes soon after our achievement of being the first to receive USFDA approval for biosimilar trastuzumab. It represents a further endorsement of the Biocon-Mylan partnership’s ability to successfully develop complex molecules to exacting quality and regulatory standards.

Biocon has been developing a high-value portfolio of biosimilar mAbs and insulins in partnership with Mylan for the US market. This biosimilar Pegfilgrastim is the second from Biocon-Mylan’s joint portfolio to receive approval in the US. It is one of the 11 biosimilars being co-developed with Mylan for the global marketplace. It is projected that biosimilars will generate savings of  54 billion USD in direct spending on biologic drugs in the U.S. between 20172026.