Bio-therapeutics - Fast Facts

Bio-pharmaceuticals

Australia’s bio-pharmaceuticals industry includes around 50 global research-based pharmaceutical companies and more than 400 locally-owned medical biotechnology firms operate in Australia. Together, they employ in excess of 40,000 highly-skilled Australians, generate nearly $4 billion in exports each year (25% more than the car industry), invest over $1 billion in research and development (R&D) and deliver medicines and vaccines that millions of Australians use every day to live longer, healthier and more productive lives.

Pharmaceutical Industry Working Group

The Pharmaceutical Industry Working Group (PIWG) was established in June 1998 to provide a forum where Government and industry representatives could discuss key issues relevant to the growth and development of the pharmaceuticals industry.

The Group is chaired jointly by the Minister for Innovation and the Minister for Health, and comprises key leaders of originator and generic pharmaceutical manufacturers, biotechnology companies, over the counter and complementary medicine companies and research institutions and the Chief Executive Officer of the National Health and Medical Research Council.

Biologics & Biosimilars

Biopharmaceuticals are commonly referred to as biologics, biologicals or large molecule medicines, and distinct from small molecule medicines that are chemically synthesised, are based on biological sources, such as bacterium or yeast.

Examples of biopharmaceuticals include vaccines, blood or blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein and living cells.

In small molecule medicines a copy (a product with the identical active ingredient) is called a generic, but biologic medicines can only ever be similar due to their biological bases, thus attracting the name 'biosimilar' medicines.

Biologics and biosimilars can consist of (relatively) smaller molecules such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies.

Of the world’s 10 top-selling prescription medicines, seven are biologics. L’Agence nationale de sécurité du médicament et des produits de santé (L’ANSM, France) has produced the following list of major products and the years in which their patent protection ends, or had ended:

 2011 - Pfizer/Amgen’s Enbrel (etancercept); 
 2014 - Roche’s Herceptin (trastuzumab); 
 2015 - Roche’s MabThera ( rituximab) and AstraZeneca’s Synagis (palivizumab); 
 2016 - AbbVie’s Humira (adalimumab) and Merck KGaA’s Erbitux (cetuximab); 
2017 - Novartis’ Xolair (omalizumab); 
2018 - Biogen’s Tysabri (natalizumab) and Roche’s Avastin (bevacizumab); and 
2019 - Bristol-Myers Squibb’s Orencia (abatacept).

(Quoted in Pharma Times / April 2014)

Personalised Medicine

Personalised medicine is term that refers to a growing trend in medicine; the practice of defining treatment according an individuals’ genetic and phenotypic information. It promises better management of diseases that will bring benefits to the economy, society and people’s quality of life via tailored diagnosis, prognosis, treatment and prevention of disease in an individual. It is making a huge impact in areas of medicines such as rheumatology and oncology.

Giving the same treatment to every patient with a particular disease is not economical because many of these patients will not respond. It also increases the potential of serious side effects developing. Personalised medicine enables clinicians to use genetic markers to determine a patient’s suitability for a treatment.

Stem Cell Treatments & Regenerative Medicine

Stem cell-based therapies are showing potential to work at the source of many diseases including diabetes, Parkinson's, Alzheimer's and certain cancers. Should the regenerative properties of stem cells be fully harnessed, there is potential to repair damaged regions of organs including the heart and brain and re-grow blood vessels. Stem cells may offer the possibility of treating disease and disability that has remained stubbornly off-limits to intervention and may now become treatable. Spinal cord damage could be corrected, and the clock could finally be wound back on neurodegenerative diseases.

Although the clinical application of stem cells can be traced back to the 1950s when the first bone marrow transplants were performed, there has been an explosion in stem cell research since then. Significant advancements in research have been made in the 15 years that have passed since the human embryonic stem cell (hESC) was first described.

Stem cell exploration has come a long way and research is ongoing, as are efforts by stem cell companies in developing novel therapies that pledge to deliver a new paradigm in medicine. However it is early days in terms of therapies reaching patients.

Stem cell therapies are part of a broader area of medicine known as regenerative medicine, which seeks to unravel the basic mechanisms of the regenerative process, enabling doctors to prevent, halt and reverse damage to vital organs due to disease, injury or genetic conditions.