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 Budget 2018-2019: our three key areas for intellectual property

Biotechnology companies and generic pharmaceuticals are the winners and celebrities are the Biggest Losers in some intellectual property-related measures in last night’s Australian Federal Budget.  Below, we set out the three key areas of interest from our first reading. Swap it! Boost for generic and biosimilar awareness campaigns The Budget will fund measures to increase the use read more...
Subjects: Media

Biosimilars: balancing access to affordable medicines with safety

Biological medicines (biologics) are agents derived from a biological source.  As a consequence, they are complex and there is a high degree of variability between molecules of the same active substance.  Biosimilars are medicines that are closely related, pharmaceutically and therapeutically, to their reference biologic.  However, biosimilars are not identical to, and cannot be characterised read more...
Subjects: Uncategorized

Don’t you wanna dance with me? US Supreme Court to hear Amgen v Sandoz biosimilars case

The US Supreme Court has granted petitions for certiorari in Amgen v. Sandoz confirming that the Court will examine the operation of the “patent dance” regime under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), as well as clarifying when notice of commercial marketing can be given. Biosimilar boffins and patent pedants will read more...
Subjects: Patents

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...