Mylan and Biocon's Fulphila becomes first FDA-approved biosimilar of Amgen's Neulasta

The FDA has granted approval to Mylan and Biocon’s Fulphila, the first biosimilar version of Amgen’s Neulasta (pegfilgrastim) to be approved in the US. The pair’s second authorised biosimilar in six months, Fulphila has been approved to reduce the duration of febrile neutropenia in patients treated with chemotherapy in certain types of cancer.

The drug had originally been knocked back by the US regulator over manufacturing data. The FDA has also rejected Neulasta biosimilar candidates from Novartis and Coherus Biosciences.

Mylan and Biocon confirmed they would be looking to launch Fulphila in the coming weeks; it is estimated that the newly-approved product could generate around $550 million for the pair in 2022. The originator product Neulasta generated $4.53 billion for Amgen throughout 2017 – 21% of the company’s total sales. The news of this approval sent Mylan’s shares rising by 5.2%, while Amgen’s fell by 1.7%.

"I couldn't be prouder of this approval for Fulphila, the first alternative option for pegfilgrastim approved in the US, as it represents an important milestone for patients and further demonstrates Mylan's continued fight to expand access to medicine," remarked Mylan CEO Heather Bresch.  "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 US, 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 US and beyond."

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