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FDA Approves Fulphila

U.S. FDA Approves Fulphila (pegfilgrastim-jmdb), the First Biosimilar to Neulasta

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 4, 2018 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer.

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, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment.

Mylan CEO Heather Bresch commented:

Mylan President Rajiv Malik added:

As a global leader in the development and manufacturing of complex products, Mylan has a portfolio of 20 biosimilar and insulin analog products – one of the industry's largest and most diverse portfolios – and deep experience with more than 60 marketing authorizations for biosimilar products worldwide.

Mylan was the first company to receive FDA approval of Ogivri, a biosimilar to Herceptin (trastuzumab), in late 2017 and has continued to obtain regulatory approvals for biosimilar trastuzumab in nearly 30 additional countries around the world.

Biocon CEO & Joint Managing Director, Dr. Arun Chandavarkar, said:

The approval for Fulphila was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that the product is highly similar to Neulasta. The data demonstrated that there were no clinically meaningful differences between the biosimilar product and Neulasta in terms of safety, purity and potency.

Neulasta had U.S. sales of $4.2 billion for the 12 months ending March 31, 2018, according to IQVIA.

Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Do not administer Fulphila to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Splenic rupture and sickle cell crisis, including fatal cases, can occur following the administration of Fulphila. Discontinue Fulphila in patients with Acute Respiratory Distress Syndrome and consider dose reduction or interruption in patients with glomerulonephritis. The most common adverse reactions are bone pain and pain in extremity.

Bringing Access to Biologics

Biologic drugs, like Neulasta, represent a large and increasing portion of the overall prescription drug market. They are important in the treatment of many chronic and acute diseases, including cancer. However, these drugs can cost far more than traditional prescription drugs, and their cost can prohibit access. According to a survey from the American Society for Clinical Oncology, more than half (56%) of respondents said they were very or somewhat concerned they could afford treatment. Biologics accounted for 70% of drug spending growth between 2010 and 2015.

Biosimilar medicines are deemed by FDA to be highly similar to an already-approved biologic product. They fill an urgent and unmet need for more affordable alternatives to biologic therapies, increasing access and providing savings for patients and the overall healthcare system. It is projected that biosimilars will generate a savings of $54 billion in direct spending on biologic drugs in the U.S. between 2017 and 2026.

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