- The Food and Drug Administration has given Pfizer approval for its Epogen/Procrit biosimilar Retacrit, for all of the indications of Amgen's blockbuster Epogen, which had nearly $1.1 billion in sales in 2017.
- "While launch timing will ultimately depend on a number of factors, we are moving ahead with the preparation of our launch plans for 2018. Retacrit is expected to be available in the U.S. at a significant discount to the current wholesaler acquisition cost of Epogen and Procrit," Pfizer said in a statement.
- Retacrit is the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the U.S. to date, and is Pfizer's third approved biosimilar in the U.S. The company has six biosimilars in mid-to-late stage clinical development.
Retacrit (epoetin alfa-epbx) won approval in December 2007 in Europe. But the path to approval of biosimilars in the U.S. only came after the passage of the Affordable Care Act in 2010.
"It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products," said Leah Christl, director of Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research, in a statement.
Still, it's taken several years for Pfizer to move the copycat of Epogen (epoetin alfa) to approval here.
The company received a complete response letter after the first submission, but got a positive recommendation for approval in May 2017 from the FDA's Oncologic Drugs Advisory Committee (ODAC). Despite that, Retacrit got an unexpected rejection from the agency in June 2017, due to manufacturing violations at the McPherson, Kansas plant.
The company finally met the grade after the third try.
The approval covers treatment of anemia from chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. It's also cleared for use before and after surgery to lessen likelihood of red blood cell transfusions.
Epoetin alfa is marketed by both Amgen and Johnson & Johnson, under the brand names Epogen and Procrit, respectively. Both drugs were approved in 1989 and have enjoyed sales well over $1 billion per year for many years. Amgen also makes a competing product dubbed Aranesp (darbepoetin alfa) that captures a piece of this market.
"With the approval of Retacrit, healthcare providers now have an additional option to choose from when prescribing an [erythropoiesis-stimulating agent]," said George Rodgers, professor of medicine at the University of Utah School of Medicine, in a statement. "By providing potentially more affordable therapeutic options, biosimilar medicines can allow for the reallocation of resources to other areas of cancer care. This is positive news for the oncology community."
Approval hasn't been the only hurdle. Biosimilar uptake in the U.S. has been slow, despite several approvals and a push from the agency to increase competition. Many of the originator companies have delayed the commercialization of approved biosimilars with legal maneuvers, while others have struck deals with biosimilar developers to keep the competition at bay.
Amgen filed a motion to compel discovery from Pfizer's Hospira unit regarding two patents protecting Epogen, which the U.S. District Court for the Delaware turned down. Amgen then appealed to a federal court, but the ruling was upheld in August 2017, leaving Pfizer unit free to continue unopposed.