FDA News

FDA approves Udenyca, biosimilar to pegfilgrastim, for patients receiving myelosuppressive chemotherapy

The FDA approved pegfilgrastim-cbqv for use by patients with cancer who are receiving myelosuppressive chemotherapy.

Pegfilgrastim-cbqv (Udenyca, Coherus BioSciences) — a biosimilar to pegfilgrastim (Neulasta, Amgen) — is a pegylated growth colony-stimulating factor designed to decrease infections as manifested by febrile neutropenia.

It is the first drug from Coherus to receive FDA approval. The agent also is approved for use in Europe.

“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.,” Denny Lanfear, chairman, CEO and president of Coherus BioSciences, said in a company-issued press release. “We believe that competition is essential in controlling burdensome price increases, and Udenyca 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 U.S., including 340B hospitals, small clinics and small hospitals.”

The FDA based the approval of the biosimilar on what Coherus officials described as a comprehensive analytical similarity package, plus pharmacokinetic, pharmacodynamic and immunogenicity studies.

The most common adverse reactions associated with pegfilgrastim-cbqv are bone pain and extremity pain.

Pegfilgrastim-cbqv is contraindicated for patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors. It also is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

“For a number of reasons we believe the oncology marketplace is ideal for biosimilars, and we are committed to a vigorous product launch,” Chris Thompson, senior vice president of sales at Coherus, said in the release. “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.”

The FDA approved pegfilgrastim-cbqv for use by patients with cancer who are receiving myelosuppressive chemotherapy.

Pegfilgrastim-cbqv (Udenyca, Coherus BioSciences) — a biosimilar to pegfilgrastim (Neulasta, Amgen) — is a pegylated growth colony-stimulating factor designed to decrease infections as manifested by febrile neutropenia.

It is the first drug from Coherus to receive FDA approval. The agent also is approved for use in Europe.

“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.,” Denny Lanfear, chairman, CEO and president of Coherus BioSciences, said in a company-issued press release. “We believe that competition is essential in controlling burdensome price increases, and Udenyca 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 U.S., including 340B hospitals, small clinics and small hospitals.”

The FDA based the approval of the biosimilar on what Coherus officials described as a comprehensive analytical similarity package, plus pharmacokinetic, pharmacodynamic and immunogenicity studies.

The most common adverse reactions associated with pegfilgrastim-cbqv are bone pain and extremity pain.

Pegfilgrastim-cbqv is contraindicated for patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors. It also is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

“For a number of reasons we believe the oncology marketplace is ideal for biosimilars, and we are committed to a vigorous product launch,” Chris Thompson, senior vice president of sales at Coherus, said in the release. “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.”