FDA Approves Inflectra, First Monoclonal Antibody Biosimilar

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On April 5, 2016, the U.S Food and Drug Administration approved the second biosimilar in the United States, which is infliximab-dyyb (Inflectra), a biosimilar to inflixamab (Remicade). Inflectra is manufactured by Celltrion, Inc. for Hospira, a Pfizer company, and will be administered by intravenous injection for many of the same indications as Remicade, the originator/reference drug. 

Although the biosimilar of Remicade has just been introduced to the U.S market, Inflectra and other Remicade biosimilars have already been introduced to major European markets such as Germany, France, Italy, Greece, Spain and Austria.

According to the FDA, Inflectra can be prescribed to treat the following patients:

• Adult and pediatric patients over age 6 who have moderate to severely active Crohn's disease and have not had success with conventional therapy
• Adult patients who have moderate to severely active ulcerative colitis and have not had success with conventional therapy
• Adult patients who have chronic severe plaque psoriasis
• Patients who have moderate to severely active rheumatoid arthritis - to be used in combination with methotrexate
• Patients who have active arthritis of the spine
• Patients who have active psoriatic arthritis

As a reminder, biosimilars are biological products, meaning they are derived from living organisms such as humans, animals, yeast and microorganisms. In order to be approved, biosimilars must be extremely similar to a biological product that has already been approved, and clinically speaking, there must be no differences in safety and effectiveness when compared to the biologic or reference product.

In addition to being only the second biosimilar approved by the FDA, Inflectra is the first monoclonal antibody biosimilar to be approved. Monoclonal antibodies are made by just a single clone of cells or cell lines from a parent cell, and though they are very expensive, they are utilized widely for different disease states such as cancer, psoriasis and rheumatoid arthritis.

Regarding the dispensing of Inflectra, it is important to note that it must receive approval for dispensing by a physician since the FDA guidance states that it has “not” been approved as an interchangeable product.

With a new biosimilar hitting the market, it is important for entities that provide pharmacy benefits to be aware of how this could affect future pharmacy benefit spend. There is a good chance that pharmacy benefit managers will hold up the dispensing of biosimilars in order to maintain the hefty rebates they receive from the high cost specialty brand/originator products. As such, this is an example of the value of retaining an expert in the pharmacy benefit industry, like PBIRx, to review your PBM contract language so that you have a clear understanding of how biosimilars are being treated, i.e. excluded/included from formularies, pricing guarantees, discounts, and copay tier appropriation.  

For help understanding your PBM Agreement, call and request a courtesy review of your PBM Agreement with one of our friendly and experienced PBM Experts prior to signing a three year PBM Agreement, which could be great for the PBM profitability, but not as good for your bottom line pharmacy benefit spend. Please call (888) 797-2479 or fill out our contact form on our website.