Pfizer’s generic injectables company, Hospira, received a complete response letter (CRL) for their proposed biosimilar of epoetin alfa, also known as Epogen and Procrit, following manufacturing issues cited by the Food and Drug Administration (FDA) in a warning letter in February.
The warning letter was issued following an FDA inspection of a McPherson, Kansas facility, listing significant GMP violations for finished pharmaceuticals, though unrelated to the production of epoetin. In its warning letter, the FDA said the facility did not thoroughly investigate unexplained discrepancies in batches or components; failed to establish valid in-process specifications, or follow written contamination prevention procedures; nor establish appropriate laboratory controls.
Epogen, developed by Amgen, was first approved in 1989. Along with the company’s related product, Aranesp (darbepoetin alfa), the two totaled more than $3.3 billion in global sales last year. Meanwhile, Johnson & Johnson’s identical licensed version, Procrit brought in over $1 billion worldwide.
Pfizer submitted a corrective and preventive action plan to the FDA in March and has been working to address the items outlined in the warning letter, the company said.
Hospira, acquired by Pfizer in 2015, has had several issues in maintaining sterility, recently recalling 59 lots of injectables distributed over the past six months.