Biologics

What is a biologic?

The main difference between a biologic drug and other drugs is their size and complexity. Normal drugs (such as antibiotics and painkillers) are small, simple molecules that can be manufactured in laboratories.

However, biologics are so large and complex that scientists, even today, cannot manufacture them. Biologics are therefore "farmed" or grown from living organisms (such as yeast cells) that have been genetically modified to produce these complex substances.

These complex molecules are then "cleaned" to remove impurities, folded in a form that makes them work effectively and often modified with complex sugar molecules on their surfaces to make them more stable and efficient.

It is for this reason they are called biologics - because they are produced through complex biological processes. If one uses the analogy of a normal drug being compared to a bicycle, then a biologic drug would be equivalent to a F1 fighter jet, both in size and complexity.

Their efficacy of biologic treatment in psoriasis, inflammatory bowel disease, rheumatoid arthritis, asthma, cancers and some eye and blood disorders has offered hope to many patients who have exhausted all other avenues.

Biologics include a wide range of products such as vaccines, blood and blood forming drugs, hormones, target specific antibodies and recombinant therapeutic proteins.

History

The production of biomedicines - that is, drugs being produced through biological processes - began in the 1980s with the development of recombinant proteins or cloned gene products such as insulin for diabetes.

Using industrialised techniques that were extended from the research laboratory tools into a manufacturing environment, companies found they could produce very complex biological molecules.

There are currently 370 biopharmaceuticals in clinical trials, targeting more than 200 serious diseases.

How do biologics differ from conventional drugs?

Comprising very complex and large proteins, biologics cannot be manufactured, but must be grown from living cells or other organisms. In contrast, normal drugs are small, simple molecules that are manufactured through traditional chemical processes. Because of their size, most biological drugs cannot be ingested as a pill, as they will be seen as protein food to the body and will be digested and inactivated by intestinal enzymes. They are, therefore, usually injected.

How can I benefit from biologics?

As biologics often represent the latest biomedical research, they can be the most effective means of treating a variety of illnesses when conventional treatment fails. Some also offer solutions where no treatment was previously available.

One example is rheumatoid arthritis, which can be a crippling disease and for some sufferers and merely getting out of bed in the mornings can be a painful, lengthy process.

Many of the drugs currently available for the treatment of rheumatoid arthritis only slow down the disease's progression, while biologics - if prescribed early - may halt the disease progression and, in some cases, may send the disease into remission.

In the area of oncology clinical experience has shown that, in the early treatment of a type of breast cancer known as HER-2 positive breast cancer, the mortality rate from the disease is halved when patients are treated with a well known biologic.

Another therapeutic area showing great success is ankylosing spondylitis (AS), or arthritis of the spine. Sufferers live with constant back pain and lack of mobility and functionality.

Improved disease outcomes is thus a big consideration, while quality of life is an additional benefit due to the improvement of these outcomes.

Improved disease outcomes is especially important when viewed from a cost perspective, leading to indirect and long-term savings such as keeping patients employed, minimising sick leave requirements and decreasing hospitalisation.

Do all medical schemes pay for biologics?

In South Africa, biologics are not a first line treatment and strict guidelines are in place for their use.

If, in the opinion of the treating specialist, a patient insured by a medical scheme needs to have access to a biologic, the medical scheme will consider the approval of the biologic according to the guidelines stipulated for the treatment of that particular illness. These guidelines differ from scheme to scheme and are also different for different illnesses. Often these guidelines are drafted by the specialists themselves, such as the South African Rheumatoid Arthritis Association (SARAA) or the South African Oncology Consortium (SAOC).

As the patient, you need to consult with your specialist in terms of what treatment options are available and find out your medical scheme's stance on the reimbursement of biologics for the treatment of your illness. You can obtain a copy of the guidelines for the treatment of your illness from your medical scheme. A medical scheme is obliged to provide you with a copy of this guideline, as this is your right according to the Medical Schemes Act 131 of 1998.