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Key Messages

• Biotherapeutics are an integral and valuable tool for modern medicine to treat and prevent serious illnesses and disease, such as cancer, multiple sclerosis and rheumatoid arthritis.
• Manufacturing biotherapeutic medicines is very complex and requires very sophisticated production, control and regulatory processes.
• Strong intellectual property rights remain a crucial incentive for innovation into new medicines.

Background

In the last 30 years, biotherapeutics have become an integral and valuable part of modern medicine. Insulin, used by diabetics to regulate blood sugar, was the first modern medicine produced using biotechnological methods. Since then, many biotherapeutic medicines have been developed and licensed to treat serious illnesses including cancer, heart disease, multiple sclerosis, anemia and rheumatoid arthritis. Biotherapeutics have a good track record with patient safety and in some instances are more efficacious and safer than conventional medicines due the ability to target specific molecules within the human body.

Unlike most conventional chemical drugs like aspirin and antibiotics, manufacturing biotherapeutics is complex as they are larger compounds in both size and structure and can be sensitive to environmental conditions. They require very sophisticated production and control processes and are dependent upon the host cells of living organisms to produce the necessary active pharmaceutical substances required for treatment.

In 2008, 633 biotherapeutic medicines were under development, including 254 for cancer (1).  As with all medicines, the research and development process for biotherapeutics involves a high degree of scientific and economic risk. It is estimated that an investment of $1.2 billion (US) is required to develop one new medicine (2).   Thus to continue research into new biotherapeutics, strong intellectual property rights remain a crucial incentive for innovation.

(1) PhRMA 2008

(2)Tufts University Centerfor the Study ofDrug Development