BIOSIMILARS FOR INDIVIDUAL INDICATIONS

Biopharmaceuticals have considerably improved the treatment of many health conditions and illnesses. And for ever more medical specialties, there are also biosimilars, successor products with highly similar API, available.

Whether it’s in rheumatology, dermatology, gastroenterology or oncology: Learn more about which patient groups benefit from which biosimilars, which are the most important active pharmaceutical ingredients and how they work here.

ILLNESSES THAT CAN BE TREATED WITH BIOSIMILARS

Cancer

According to the Robert Koch Institute, almost 500,000 people are diagnosed with cancer Germany-wide every year. After illnesses linked to the cardiovascular system, cancer is among the most common causes of death in Germany. However, thanks to modern treatment methods, such as biopharmaceuticals, the conditions for affected patients have continuously improved in the past few years.

Importance of biopharmaceuticals in cancer treatment:

Biopharmaceuticals complement and supplement established treatment methods, for example, the API filgrastim is efficient against common side effects of cancer and radiation therapy. Especially over the course of the last few years, the use of these highly complex pharmaceuticals has improved cancer treatment options significantly, and has therefore also ameliorated the prognosis of many cancer patients. Further, more and more of these biopharmaceuticals are available as biosimilars. While chemotherapy is more comprehensive and thus less specific in its effects and can also affect healthy cells, biopharmaceuticals are oftentimes more specific and therefore able to eliminate cancer cells in a more targeted way.

 Important biosimilar APIs:

Filgrastim

Filgrastim, available as a biosimilar since 2008, is used to supplement cancer treatments, more specifically in the treatment of so-called neutropenia. Neutropenia occurs when, due to chemo or radiation therapy, the amount of neutrophils (an essential part of our immune cells, i.e. white blood cells) decreases drastically.

Trastuzumab

Trastuzumab, available as a biosimilar since 2018, is an antibody which is used, for example, in breast cancer treatment, and which can inhibit the growth of specific cancer cells. This API demonstrates important progress for many patients. Trastuzumab is authorised, among other indications, for the treatment of early stage, locally advanced or metastatic breast cancer. It is mostly administered intravenously, either by itself or in combination with chemotherapeutics.

Rheumatism

Importance of biopharmaceuticals in rheumatism treatment:

For many patients for whom the chemical basis therapy (e.g. with methotrexate) is not ideal, biopharmaceuticals can cause enormous improvements in quality of life. Biopharmaceuticals against rheumatism affect, amongst others, inflammatory neurotransmitters. In this way they open up possibilities for patients to return to – at least to some extent – a healthy life.

Important biosimilar APIs:

Adalimumab

Adalimumab, available as a biosimilar since 2018, is used, for example, to treat severe forms of rheumatoid arthritis. It inhibits inflammation processes of the immune system by tethering itself to the tumor-necrosis-factor-alpha (TNF-α, a neurotransmitter which plays an important role in inflammations) and blocking its effects. As a result, less inflammatory neurotransmitters are released.

Etanercept

The TNF-α-blocker etanercept, available as a biosimilar since 2016 is an anti-rheumatic pharmaceutical. Through its function as a TNF-α-blocker, etanercept inhibits the rheumatoid inflammation as well as possibly preventing further or emerging joint damage.

Crohn's Disease

Crohn’s disease is a chronic inflammatory disease of the digestive tract, affecting patients intermittently in the form of ulcers which can develop in different parts of the body between mouth and after, though they occur most frequently in the intestines. Approximately more than 400,000 patients in Germany are suffering from an inflammatory bowel disease like Crohn’s disease or colitis ulcerosa. 

Importance of biopharmaceuticals in the treatment of Crohn’s disease:

Biopharmaceuticals in this case are mostly used if other APIs did not show sufficient effects. The antibodies block the inflammation processes. Patients who are treated with biopharmaceuticals are often less, or no longer at all, dependant on steroids (cortisone).

Important biosimilar API:
Infliximab, available as a biosimilar since 2013, is a so-called partially human antibody. Crohn’s disease patients generally release inflammatory neurotransmitters at a constantly elevated rate. Infliximab is the first biosimilar which is authorised for the treatment of chronic inflammatory diseases – rheumatoid joint diseases, plaque psoriasis and chronic inflammatory bowel diseases.

Psoriasis

Psoriasis is a chronic skin and joint disease, affecting roughly two million people in Germany. Typical symptoms of psoriasis include dry patches of skin on knees, elbows or scalp, which are usually accompanied by severe itching.

Importance of biopharmaceuticals in the treatment of psoriasis:

Especially for patients for whom the basis therapy is not working sufficiently, biopharmaceutical APIs can oftentimes cause considerable improvements – by inhibiting the inflammatory reactions of the body. With good tolerability, the treatment can be continued permanently enabling patients to have skin almost free of symptoms within a few weeks. Studies have shown that associated therewith is also a significant improvement in the quality of patients’ lives.

Important biosimilar API:

Etanercept

Etanercept, available as a biosimilar since 2016 is a TNF-alpha-blocker. It inhibits not the entire immune system, but blocks specific inflammatory neurotransmitters, which can cause psoriasis.

Patients with psoriatic arthritis – an inflammation of the joints approximately a third of patients develop – can also be treated with etanercept.

Anaemia

Anaemia stands for a lack of haemoglobin (red blood pigment) and/or erythrocytes (red blood cells) as well as low haematocrit levels (share of blood cells in the blood). There are various causes for anaemia; they can occur as a concomitant of chronic renal insufficiency or as a consequence of cancer. 

Importance of biopharmaceuticals in the treatment of anaemia:

The use of biopharmaceuticals is seen as a major scientific breakthrough which also has the capacity to enormously improve the quality of life of patients. Haemoglobin and haemocrit levels can increase significantly during treatment while low levels demonstrate anaemia. Initially, biopharmaceutical APIs were only authorised and available for people with renal insufficiency requiring transfusions. Consequently, more indications, such as anaemia associated with chemotherapy or pre-operative anaemia, were added. Nowadays biopharmaceuticals are the medical standard in the treatment of anaemia.

Important biosimilar APIs:

Epoetine

Epoetine, available as a biosimilar since 2007, is a biotechnologically manufactured hormone, which stimulates the formation of red blood cells (erythrozytes) in bone marrow, thus compensating for the deficiency.

Biosimilars in oncology

In 2017, the EMA authorised the first biosimilars for cancer treatment. What does that mean for us and our health care system? (In German)

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Biosimilars bei Rheuma

From a patient’s point of view: what happens when you switch to a biosimilar

Doreen Reimann is suffering from severe rheumatism. A biological changed her life. Find out why she switched to a biosimilar anyway here. (In German)

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