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.

Advertisements

Colorectal Cancer

August 5, 2017

The National Cancer Institute reports that over 136,000 people were diagnosed with Colorectal Cancer, and over 50,000 people died from this condition in the US last year, making it the second leading cause of death from cancer in the country. Some racial groups–minorities in particular—seem to suffer from this condition more than others, according to Dr. Jonca Bull, director of the Office of Minority Health for the FDA. The minority population (American Indians, African Americans, Hispanics, and Alaska Natives) is hit hard primarily because of limited access to medical treatment and screening. The biggest remedy for treating this condition is to attack it head on by doing early detection so the patient can be referred and treated, which will decrease the number of deaths occurring from this condition.

The Signs of Colorectal Cancer

The development of polys or other precancerous growths in the rectum (or colon) can turn into colorectal cancer. However, there may not be any outward symptoms if you have precancerous growths. Screening will help your doctor see what’s going on, so the growths or questionable can be removed if needed.

Your Risk for Colorectal Cancer increases if you:

  • Smoke
  • Have diabetes
  • Have a history of ulcerative colitis, Crohn’s disease or inflammatory bowel disease
  • Have a family history of colorectal cancer
  • Have certain genetic syndromes (such as FAP or Lynch)
  • Have a personal history of colon polyps or colorectal cancer

You should see your doctor also if you have any of these Symptoms, even though they do not necessarily indicate colorectal cancer:

  • Frequent bloating, fullness, cramps or gas pains
  • Unexpected Weight loss
  • A change in bowel habits (such as constipation, diarrhea and the sensation that the bowel does not empty completely)
  • Bright or dark blood in stool
  • Stools narrower than usual
  • Vomiting
  • Feeling very tired

The Benefits of Screening

Thanks to screening, surgery and medication, a lot of people with colorectal cancer are seeing a longer lifespan. Companion diagnostics are being conducted to determine if some people are less receptive to some medications than others due to genetic mutations.

There are also clinical trials available for those wishing to participate in research to discover new approaches to treating the condition. If you are considering a clinical trial, make sure you talk this over with your family and your health care provider.

How can I reduce my risk?

Your race, ethnicity, age, medical history, and other factors may increase your risk for colorectal cancer. Here are some ways to reduce the risk:

  • Don’t smoke and avoid second-hand smoke
  • Exercise often and vigorously
  • Eat healthy (adopt a diet high in fruits and vegetables but low in processed and red meats)
  • Drink alcohol in moderation
  • Maintain a healthy weight