United States FDA gets serious about biosimilars

The most significant advances in medical treatments are being made with biological products.  As biological medicines are significantly more expensive than traditional small molecule drugs, upward pressure is being placed on health spending. For example, in the United States, biological medicines accounted for 40% of all prescription drugs spending and 70% of the increase in read more...
Subjects: Patents

Is the cure in your DNA? – The rise of biopharmaceuticals and pharmacogenomics-led therapy

15 years has passed since the Human Genome Project, involving the identification and mapping of all the genes of the human genome, was declared complete. Work on the project (which formally started in 1990 and spanned 15 years) involved international collaboration between scores of scientific researchers and funding of ~US$3 billion. As one of the read more...

The Trans-Pacific Partnership’s IP provisions: Biologics and biosimilars, copyright and privacy

The Trans-Pacific Partnership (TPP) was concluded on 5 October 2015, after 8 years of negotiations. Its twelve signatories, who together account for 40% of world GDP, are Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, United States and Vietnam. The details of the agreement have yet to be released, but a number read more...