What are biopharmaceuticals?
Biopharmaceuticals are defined as pharmaceuticals manufactured by biotechnology methods, with the products having biological sources, usually involving live organisms or their active components.
The methods and techniques that involve the use of living organisms (such as cells, bacteria, yeast and others) as tools to to perform specific industrial or manufacturing processes are called Biotechnology.
Biotechnology is delivering significant advances in human healthcare. Entirely new medicines are being created, notably for rare or previously untreated diseases. Biotech production methods provide safer versions of existing treatments in unlimited quantities. Biotechnology has revolutionised the research and development of new medicines and allows better product targeting for specific diseases and patient groups.
A greater understanding of the genetic causes of disease allows early detection and treatment, and the new field of gene therapy may even herald the possibility to cure diseases, not simply treat them.
New Solutions Now…
Biotech medicines already account for around 10 - 15% of the current pharmaceutical market and the sector is outperforming the market as a whole. Significantly, more than one-fifth of new medicines launched on the world market each year are now biotechnology-derived. This will likely grow with the scientific advances currently underway; and the application of biotechnology in healthcare is leading to an increasing number of innovative products.
Biotechnology has already provided a wide variety of products for chronic and rare diseases, such as some cancers, hepatitis C, chronic renal failure, haemophilia, diabetes, Fabry’s disease, growth deficiency, multiple sclerosis and Crohn’s disease.
…and in the Future
Biotechnology will continue to provide new breakthroughs in medical research in the years to come, leading to treatments in fields which have previously eluded us (including AIDS, cancer, asthma, Parkinson’s disease, Alzheimer’s disease), as well as continuing to provide alternatives to existing conventional treatments.
The use of biotechnology to develop novel medicines has several specific advantages:
1. Biotechnology allows the development and production of new substances that were previously beyond the capacity of traditional technologies. This includes the design and production of new drugs with greater potency and specificity and, consequently, fewer side effects. One example of this is the treatment for multiple sclerosis.
2. Concerns about product safety in developed countries have largely been removed thanks to the development of biopharmaceuticals. Biotechnology offers a greater control over the manufacturing process, allowing significant reduction in risks of contamination through infectious pathogens. A prime example is the blood products used to treat haemophilia.
3. Biotechnology offers better product-targeting for specific diseases and patient groups, through the use of innovative technologies, in particular, genetics. Examples include, amongst others, treatments for rare diseases and cancers.
4. Some products are not naturally created in sufficient quantities for therapeutic purposes. Biotechnology makes large-scale production of existing substances possible, for example, insulin in the field of diabetes treatment.
Key topics where EBE is currently involved are:
- Advanced Therapy Medicinal Products
- Biosimilar Medicinal Products
- Rare Diseases and Orphan Medicinal Products
- Special Provisions for SMEs
- Clinical Trials
- New Medicines Legislation
- EU’s Innovation & Competitiveness