FDA approves Fulphila, the first U.S. Neulasta biosimilar

Press enter to search
Close search
Open Menu

FDA approves Fulphila, the first U.S. Neulasta biosimilar

By David Salazar - 06/05/2018
The Food and Drug Administration on Tuesday approved Fulphila (pegfilgrastim-jmdb), a Neulasta biosimilar from Mylan and Biocon. Fulphila is the first U.S. biosimilar of the drug from Amgen and is indicated to reduce the duration of febrile neutropenia in patients treated with chemotherapy in certain types of cancer.

“Today's approval of Fulphila represents a meaningful step forward in the affordability and accessibility of cancer care in the United States,” Mylan president Rajiv Malik said. “It also is yet another confirmation of Mylan's deep scientific, clinical, regulatory and intellectual property capabilities, which are widely recognized in the industry and bolster Mylan's reputation as a partner of choice in the global effort to bring complex medicines to market.”

Fulphila is the second approved biosimilar from Mylan and Biocon’s joint portfolio. In December 2017, the two companies received approval for Ogivri, the first Herceptin biosimilar in the United States.

“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,” said Biocon CEO and joint managing director Arun Chandavarkar.

Though Fulphila is the first U.S. Neulasta biosimilar, last week, Health Canada approved Lapelga, a Neulasta biosimilar from Apotex’s Apobiologix division.

As more approvals roll in for biosimilars, FDA commissioner Scott Gottlieb has promised more action on the medications that are priced lower than their reference products.

“This summer, we'll release a comprehensive new plan to advance new policy efforts that promote biosimilar product development,” Gottlieb said. “Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health. We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products.”