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Biosimilars –The Newest Addition to the Pharmaceutical Industry

Biosimilars –The Newest Addition to the Pharmaceutical Industry

Sep 15, 2015

Biologics are among the fastest growing sector of the pharmaceutical industry. Most drugs are small molecules, and are synthesized chemically. Biologics are different in that not only are they larger molecules such as proteins, but they require a finely tuned process to be produced from  a biological source, such as a cell line.

One popular category of biologics is monoclonal antibodies. They are like the antibodies produced by your immune system, but are made to target a specific pathway. For example, the top selling biologic adalimumab is used to treat rheumatoid arthritis and several other inflammatory conditions. It works by specifically targeting a protein called tumor necrosis factor-alpha so that it cannot initiate the inflammatory response it normally does. This results in a reduction of symptoms.

antibody

Because biologics require such specialized and precise protocols to produce, they are generally very expensive. Fortunately, many biologics are coming off patent within the next few years, and a new field of pharmaceuticals has emerged—biosimilars. Biosimilars are defined by the FDA as being highly similar to the reference product, rather than being an exact copy such as with small molecule drugs. The molecules must have similar dosages, strengths, routes of use such as injection. They also undergo rigorous testing to ensure purity and effectiveness.

Why do we care about biosimilars? Because they are poised to be much cheaper than the reference products they are similar to and this offers more options to patients and doctors fighting serious illnesses. As of now there is only one biosimilar approved for use in the US, Zarxio, which is now a competitor to Neupogen. The drug is used to increase white blood cell counts in cancer patients.  It will be interesting to see how the landscape of the pharmaceutical industry changes as companies compete with biosimilar products. The market is expected to take off with estimates for 2020 ranging from 6-11 billion dollars, with competition among companies resulting in lower prices for consumers. Only time will tell.

money

 

 

Casey Raasumaa Rollins – Proofreader at Amgen and Columnist at QGITS. A Masters in Life Science from the University of Edinburgh. Linkedin

Dietary Saturated Fat Not as Harmful as Once Thought

Dietary Saturated Fat Not as Harmful as Once Thought

Jan 28, 2015

High levels of saturated fat in the blood have been implicated in heart disease. As a result, saturated fat in the diet  is generally regarded as bad for your health. A new study may change the way we perceive saturated fat in the diet. A study was conducted on individuals with metabolic syndrome. Metabolic syndrome is characterized by having three of the following: a large waist circumference, high blood pressure, high blood sugar or high triglycerides. Triglycerides are a type of lipid that accumulate in the blood stream and high levels are associated with poor health.

saturated fat

During the study, participants were  fed a slightly calorie deficient diet (about 300 calories). Every three weeks the composition of fat and carbohydrates was changed. This study design is unique in that it investigates different diets within the same individuals, rather than across a population. The researchers found that despite some diets having significantly more saturated fat than others, there was no change in serum levels of saturated fat in the blood. This is important because it means that our dietary intake of saturated fat does not effect how much saturated fat is in our bodies—meaning diets with low saturated fat are unnecessary.

Even more interesting, they found that the higher carbohydrate diets increased the levels of a fatty acid called palmitoleic acid. According to the authors, high levels of palmitoleic acid are associated with heart disease, hyperglycemia and cancer. These findings bring to light questions about the daily recommended diet, such as whether or not we should be encouraging  low levels of saturated fat and relatively high carbohydrate intake.

carbs

Clinical Trial to put Supplements to the Test in Bipolar Depression

Clinical Trial to put Supplements to the Test in Bipolar Depression

Nov 19, 2014

Bipolar disorder is a serious mood disorder, consisting of periods of mania and depression. We have treatment for both, though the treatments for depression often will not work very well. The causes on a molecular level of the disease are unknown, so a research group in Australia is tackling the disease from a new standpoint. There is some evidence to suggest that mitochondrial dysfunction can contribute to the disease. Mitochondria are the power plants of a cell, where energy is produced. In the brain because there are high levels of oxygen metabolism, the byproducts of which (free radicals) can create a situation known as oxidative stress. This oxidative stress can damage the mitochondria, in turn causing them to produce more damaging substances that cause more oxidative stress.

Drama and comedy

The researchers have designed a clinical trial using easily available supplements as an adjuvant treatment (meaning in addition to medication) for bipolar disorder, specifically the depression phase. These substances that are included in the trial are known to have a positive effect on oxidative stress. One of the supplements, N-acetyl cysteine, has been shown in a previous trial by the group (2008) to be effective in improving some aspects of bipolar and schizophrenia. In the current trial they are adding  a slew of other vitamins, to see if there is improvement in the depression phase of bipolar disorder.

Some of the vitamins they are adding include vitamin D3, an antioxidant that deficiency of which can lead to low mood; Vitamin E, which scavenges free radicals; and B vitamins which work synergistically with  the mitochondria  to improve function. The study is going to be finished in 2015.

vitamins

Broccoli Compound Reduces Autism Behaviors

Broccoli Compound Reduces Autism Behaviors

Oct 21, 2014

broccoli

Autism Spectrum Disorder is a disease that affects approximately 1 out of every 68, and occurs mostly in males. It is characterized by an impairment of social communication, as well as repetitive behaviors (such as rocking) and difficulties with language. Up until this point there is no known cure for autism.

Researchers Sing et al at Harvard medical school have found a potential candidate for a new drug—derived from broccoli sprouts. Sulforaphane is a chemical compound found in cruciferous plants such as broccoli and cabbage. It was chosen for the study for several reasons, one of which being low toxicity because it is derived from a food source.

During metabolism, or the transformation of one chemical to another in a living cell, reactive oxygen species such as free radicals are produced. These reactive oxygen species can cause damage known as oxidative stress.  Sulforaphane counteracts this by turning on genes to protect cells from damage. It also turns on genes that protect against DNA damage and neuroinflammation. Oxidative stress, DNA damage and neuroinflammation are all associated with Austism Spectrum Disorder. This is one of the first studies that addresses these problems as a potential pathway for treatment.

brain

In this pilot study 22 male participants were treated for 18 weeks with either sulforaphane or a placebo, and then evaluated by both caregivers and physicians for behavioral changes. A placebo is a non-active compound given to compare with the effectiveness of the drug. They found that irritability, lethargy and hyperactivity were improved among those who were treated with sulforaphane. Repetitive movements, also known as stereotypy, were also reduced. Behavior was measured 4 weeks after stopping treatment, and the participants reverted to their usual behaviors, suggesting that the changes were in fact from treatment with the compound.

First of its Kind–a Blood Test for Depression?

First of its Kind–a Blood Test for Depression?

Sep 30, 2014

depression

Depression is the leading cause of disability in the world. It is a debilitating illness characterized by loss of energy, lack of pleasure in life and potentially suicidal thoughts. Diagnosis of this sickness is often done by family physicians, and is based on the patient’s reports of their symptoms. The problem with this system is that patients often under-report symptoms so diagnosis is difficult. Fortunately there may be another way.

 

A recent study in Nature published by Dr. EE Redei et al at Northwestern University in Chicago Illinois suggests that depression has biomarkers, or parameters that are measurable, in the blood stream. Before DNA gets translated into protein, it first gets converted into RNA transcripts. This is what they used for biomarkers—they extracted RNA from the blood of patients with and without Major Depressive Disorder and looked for differences. They found three markers that differed between those who were sick and those who were not.

Blood-test-tube

Besides antidepressants, a common treatment for depression is cognitive behavioral therapy. Excitingly enough, they found transcript differences between those who improved from the therapy and those who did not. This indicates that the markers may be a measurable parameter of the severity of the illness. This means the blood test could be used to determine if treatment is working.

 

Having a blood test to diagnose depression is a huge step forward in the treatment of mental illness. If we could develop tests that catch these illnesses before they manifest themselves fully we could treat them before they get out of hand and the patients require hospitalization. This would keep healthcare costs down and improve the quality of life for many people.