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First biosimilar to cancer drug Neulasta approved by FDA

Fulphila (pegfilgrastim-jmdb) is the first biosimilar to Neulasta (pegfilgrastim) to gain approval from the US Food and Drug Administration (FDA). The Mylan GmbH medicine was approved as a treatment to reduce the risk of infection as suggested by febrile neutropenia (fever caused by a lack of certain white blood cells) in patients with cancer (other than bone marrow cancer) who are receiving myelosuppressive chemotherapy with a clinically significant incidence of febrile neutropenia. 

The latest addition to the list of FDA approved biosimilars is based on the Amgen biological product Neulasta, a subcutaneous (under the skin) injection used as a white blood cell booster to improve the immune system of certain cancer patients undergoing strong chemotherapy. In a key study of 928 patients with breast cancer, only one percent of patients given Neulasta every chemotherapy cycle developed infections, compared with 17 percent of those who did not receive the treatment. 

Fulphila is a man-made form of a protein that stimulates the body’s production of white blood cells, boosting its fight against infection. Approval for the biosimilar was granted following a review of evidence, including clinical safety and efficacy data.

Biosimilars are biological products that gain FDA approval following examination of data to show it is “highly similar” to an already approved biological product. Biological products are usually derived from living organisms, such as humans, animals, microorganisms or yeast. Following President Trump’s outline of plans to reduce drug costs in the United States, the FDA announced plans to streamline the approval process for biosimilars. 

Commenting on the approval of Fulphila, FDA Commissioner Scott Gottlieb MD described biologics as “some of the most clinically important but costliest products” used to promote patient 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.” Gottlieb added.

Fulphila is not the first biosimilar to gain FDA approval in recent weeks. In May 2018, the FDA approved the Hospira Inc (a Pfizer company) drug Retacrit (epoetin alfa-epbx), the first epoetin alfa biosimilar for Amgen biological product Epogen/Procrit, which is used to treat anemia in certain patients. 

Common Side Effects of Fulphila

- Bone pain

- Pain in the extremities

Serious Side Effects of Fulphila

- Rupture of the spleen

- Acute respiratory distress syndrome

- Serious allergic reactions (including anaphylaxis)

- Glomerulonephritis (acute kidney inflammation)

- Abnormally high white blood cell levels 

- Capillary leak syndrome and potential for tumor growth

- Fatal sickle cell crises have occured

Who should not take Fulphila?

Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (for example, pegfilgrastim or filgrastim products).