FDA Grants Approval to Biosimilar for Patients Receiving Myelosuppressive Chemotherapy
Officials with the FDA have approved Coherus BioSciences’ Udenyca™ (pegfilgrastim-cbqv) for patients with cancer receiving myelosuppressive chemotherapy. The drug is a biosimilar to Amgen’s Neulasta (pegfilgrastim).
Officials with the FDA have approved Coherus BioSciences’ Udenyca™ (pegfilgrastim-cbqv) for patients with cancer receiving myelosuppressive chemotherapy.1,2 The drug is a biosimilar to Amgen’s Neulasta (pegfilgrastim).1
Udenyca is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Udenyca is the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC), according the Coherus.2
The FDA’s approval of Udenyca was supported by a comprehensive analytical similarity package, as well as pharmacokinetic, pharmacodynamic and immunogenicity studies, including more than 600 healthy subjects.2
“Udenyca’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 a prepared statement.2 “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 Udenyca, but also advanced the understanding of the immunogenic response of pegfilgrastim products.”
The most common adverse reactions (≥ 5% difference in incidence compared to placebo) reported by patients using Udenyca were bone pain and pain in extremity.2 According to Coherus, patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors, such as pegfilgrastim or filgrastim products, should not use Udenyca.2
The drug is Coherus’ first to receive an approval from the FDA or the EC, which approved Udenyca on September 21, 2018. In a statement, Chris Thompson, Senior Vice President of Sales for Coherus, said company officials believe the oncology marketplace is ideal for biosimilars for a number of reasons, and they remain committed to vigorously launching products in that space.2
“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,” said Thompson, in his statement.2
Furthermore, Denny Lanfear, Chairman, CEO and President of Coherus Biosciences, said company officials believe that competition is essential in controlling price increases, and that Udenyca will play an important role in curbing those increases when the product is launched.2
“The list price of Neulasta has nearly tripled since approval in 2002 and now represents a $4 billion annual cost burden in the U.S.,” said Lanfear, in his statement.2 “Our in-depth understanding of the market will allow us to deliver significant value to patients, payors, and providers in the U.S., including 340B hospitals, small clinics and small hospitals.”
- FDA. FDA approved Udenyca (pegfilgrastim-cbqv), biosimilar to Neulasta (pegfilgrastim)—Drug Information Update. FDA Division of Drug Information email. November 2, 2018. Accessed November 2, 2018.
- U.S. FDA Approves UDENYCA™ (pegfilgrastim-cbqv) [news release]. Redwood City, CA; November 2, 2018: Coherus Biosciences. https://globenewswire.com/news-release/2018/11/02/1642328/0/en/U-S-FDA-Approves-UDENYCA-pegfilgrastim-cbqv.html. Accessed November 2, 2018.