Biosimilars

August 18, 2017

Inflectra (Infliximab-dyyb), a biosimilar of Remicade (infliximab), and Zarxio (filgrastim-sndz), a biosimilar of Neupogen (filgrastim), are in a new line of medications destined to become more commonplace in the future as more Biosimilars are approved by the Food and Drug Administration (FDA).

Dr. Leah Christl (Associate Director for Therapeutic Biologics at the FDA) tells us that in order to understand what a biosimilar is, we need to first understand what biologics (also called biological products) are.

Biologics: Medications from Biological Substances

A biologic is any medicine derived from living creatures—be it a microorganism (like bacteria and yeast), animal or human.

Dr. Christl tells us that the major difference between biologics and traditional medicines is in the source of material they are derived from. Traditional medicines are derived from chemical substances and byproducts and are easy to replicate.

Because biologics come from living organisms, they are just as unique as the organisms they come from. So there is no one exact recipe one can follow to replicate a biologic. Thus, the procedure for replicating a biologic is more difficult than with traditional medicines.

Right now, biologics are becoming a popular commodity in the pharmaceutical world   As with traditional medicines, biologics also undergo a strict process to get approved by the FDA.

What Are Biosimilars?

A biosimilar is a biologic that closely resembles the design of another biologic that is already approved by the FDA (commonly referred to as the reference product).

Unlike generics, which are replicas of brand name drugs, biologics are not as easy to replicate because it’s impossible to create an exact replica of an existing biologic. Therefore, the new brand will be similar but not identical to the original.

In order for a biosimilar to be approved, the FDA has to ensure the biosimilar has no significant differences in structure from the reference product. Thus, the biosimilar must produce the same effect, same method of being administered and have the same potency per dosage as its reference product to be considered an authentic biosimilar.

As stated earlier, Inflectra is the biosimilar of Remicade (infliximab). Like Remicade, Inflectra is used to treat:

  • plaque psoriasis
  • psoriatic arthritis
  • rheumatoid arthritis
  • Crohn’s disease
  • ulcerative colitis
  • ankylosing spondylitis

Respiratory infections are a common side effect of Inflectra. These symptoms include:

  • headache
  • sinus infections and sore throat
  • stomach discomfort
  • coughing

Sometimes, people experience chills, chest pain, low or high blood pressure, shortness of breath, itching, rash, or fever for up to two hours after taking the Inflectra infusion. It is recommended Health care professionals become well-knowledgeable about all prescription information concerning Inflectra—the good and the bad before prescribing it to patients.

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