FDA Approves Pegfilgrastim Biosimilar

The FDA has granted an approval to pegfilgrastim-cbqv (CHS-1701; Udenyca), a pegfilgrastim (Neulasta) biosimilar, for patients with cancer receiving myelosuppressive chemotherapy, according to Coherus BioSciences, Inc, the manufacturer of the agent.

The biosimilar was also granted approval by the European Commission for the same indication on September 21, 2018.

“We are excited to announce that Coherus has received FDA approval for Udencya. I want to thank the Coherus team, our strategic partners, and the US Food and Drug Administration for this extraordinary achievement,” said Denny Lanfear, chairman, CEO and president of Coherus BioSciences. “The list price of Neulasta has nearly tripled since approval in 2002 and now represents a $4 billion annual cost burden in the [United States]. We believe that competition is essential in controlling burdensome price increases, and Udencya will play an important role in curbing that spend when launched. Our in-depth understanding of the market will allow us to deliver significant value to patients, payors, and providers in the [United States], including 340B hospitals, small clinics and small hospitals.”

Pegfilgrastim-cbqv is a PEGylated growth colony-stimulating factor designed to decrease incidence of infection from febrile neutropenia associated with patients who have nonmyeloid malignancies receiving anti-cancer myelosuppressive therapy.

The approval was based on analytical similarity data between pegfilgrastim and the biosimilar, as well as pharmacokinetic, pharmacodynamic, and immunogenicity studies of more than 300 patients. Coherus Biosciences will provide additional information on pricing and a launch date on its November 8 earnings call.

“Udencya’s robust clinical package includes a dedicated immunogenicity similarity study in over 300 healthy subjects,” said Barbara Finck, MD, chief medical officer of Coherus BioSciences. “In support of that study, and as part of our commitment to ensuring patient safety, we deployed a battery of sensitive immunogenicity assays. This effort not only supported the biosimilarity of Udencya, but also advanced the understanding of the immunogenic response of pegfilgrastim products.”

Dosing for the pegfilgrastim-cbqv biosimilar is 6 mg/0.6 mL given subcutaneously once per chemotherapy cycle; weight-based dosing is appropriate for pediatric patients weighing less than 45 kg.

Regarding safety, the most common adverse events (≥5%) associated with pegfilgrastim compared with placebo, as seen in a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer, are bone pain (31% vs 26%) and pain in extremity (9% vs 4%). In other studies, leukocytosis was reported in less than 1% of 932 patients with nonmyeloid malignancies treated with pegfilgrastim.

In the indication, there is a warning for those with fatal splenic rupture, acute respiratory distress syndrome, serious allergic reactions, including anaphylaxis, fatal sickle cell crises, and glomerulonephritis.

In June 2017, the FDA issued a complete response letter for a biologics license application (BLA) for pegfilgrastim-cbqv, requesting a reanalysis of a subset of subject samples with a revised immunogenicity assay and additional information on the manufacturing process. Coherus Biosciences resubmitted the BLA in May 2018.

In July 2018, the European Medicines Agency’s Committee for Human Use granted a positive opinion to pegfilgrastim-cbqv for the same indication.

“For a number of reasons, we believe the oncology marketplace is ideal for biosimilars, and we are committed to a vigorous product launch,” said Chris Thompson, senior vice president of sales, of Coherus Biosciences. “Our oncology-focused, highly capable and fully-staffed commercial team is in place. We are confident that our U.S.-based manufacturing network has the finished goods in inventory to meet our highest expected demand for an extended period.”

In June 2018, the FDA granted approval to pegfilgrastim-jmdb (Fulphila), another pegfilgrastim biosimilar to decrease the incidence of infection by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy.

Coherus Biosciences, Inc. U.S. FDA approves UDENYCA™ (pegfilgrastim-cbqv). Published November 2, 2018. https://bit.ly/2Rxyt8c. Accessed November 5, 2018.