Biologics: a new frontier in treating disease

Biologic medicines represent the next frontier of treatment for many previously untreatable illnesses and conditions, Medicines Australia chief executive Dr Brendan Shaw said today following the launch of a publication highlighting the value of biologic medicines.

Biotherapeutic Medicines: Grasping the New Generation of Treatments is published by the International Federation of Pharmaceutical Manufacturers & Associations, and highlights the dramatic increase in treatment options resulting from the development of biological medicines.

Biologic medicines are derived from proteins and other substances produced by living organisms, such as mammalian cells, viruses and bacteria.

“More than 350 million patients worldwide are leading healthier lives thanks to biologic medicines,” Dr Shaw said.

“These medicines are being used for the effective treatment of illnesses that were not previously treatable with simpler chemical entities.

“Biologic medicines and vaccines represent the cutting edge of medicine and have the potential to deliver the most effective means of treating and diagnosing some of humanity’s most appalling diseases.

“Over 250 innovative human-use biologics have been approved since 1990 and more than 900 are currently under development globally, targeting diseases such as cancer, AIDS, arthritis, Alzheimer’s and Parkinson’s.”

Dr Shaw said the increasing prevalence of biological treatments required sound intellectual property policy and specific regulatory standards.

“Biologics are more complex and costly to produce than chemical medicines,” Dr Shaw said.

“The level of testing and clinical studies required to compare the effectiveness of different biologic medicines presents regulators in Australia and elsewhere with a new set of challenges.

“Biologic medicines and their generic copies, called biosimilars, are often not interchangeable with each other in the same way that chemical-based medicines are, so regulatory approval systems need to evolve to cope with evaluating such medicines.

“Intellectual property protection is another crucial policy element as it underpins further research and development of biologic medicines and ensures Australians have access to these medicines as soon as they become available.

“This includes assurances that policies on things like patents and clinical trial data are up-to-date with the requirements of biologics medicines.”

Biotherapeutic Medicines: Grasping the New Generation of Treatments is available from the IFPMA website


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