Biosimilar approvals deemed “too slow”

While FDA’s approval of infliximab-dyyb (Inflectra, Celltrion), a biosimilar to Remicade (Janssen Biotech) for rheumatoid arthritis, Crohn’s disease and other conditions is positive, FDA’s approval pace for biosimilars is too slow, according to a pharmacy benefit manager (PBM).

FDA approved Inflectra, administered by infusion, a year after the agency’s first biosimilar approval, filgrastim-sndz (Zarxio, Sandoz) last March.

“Inflectra’s approval comes more than a year after the first biosimilar was approved in the United States,” said David Lassen, chief clinical officer for Prime Therapeutics, a PBM that serves more than 26 million Americans. “If approvals continue to be this slow, it will be many years for biosimilars to have an impact on high drug prices. Americans can’t afford to wait, and more needs to be done to slow the unsustainable growth in drug costs.”

Related: Another win for biosimilar arthritis drugs

The PBM encourages regulators and FDA to speed up approvals and finalize their decisions on this “complex and influential issue in our industry,” the company said in a statement. “Significant issues still remain with regard to interchangability, and naming still needs to be finalized. Until these are resolved, manufacturers may be reluctant to bring more biosimilars to market.”

FDA’s approval of Inflectra is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Inflectra is biosimilar to Remicade.

“Biosimilars can provide access to important treatment options for patients who need them,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research. “Patients and the health care community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.” 

Related: 5 reasons to be concerned over proposed Medicare rule on biosimilar coding

Health care professionals are advised to review the prescribing information for detailed information about the approved uses.

The most common expected side effects of Inflectra include respiratory infections, such as sinus infections and sore throat, headache, coughing and stomach pain. Symptoms of infusion reactions may include fever, chills, chest pain, low blood pressure or high blood pressure, shortness of breath, rash and itching.  

Inflectra contains a Boxed Warning to alert healthcare professionals and patients about an increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis) and others. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including infliximab products such as Inflectra. Other serious side effects may include liver injury, blood problems, lupus-like syndrome, psoriasis, and in rare cases nervous system disorders. 

Read more: Patent litigation could hold up biosimilars