The relevance and importance of biopharmaceuticals (biologics) as modern medical treatments is clear. This relatively new group of pharmaceuticals offers more effective treatment and management of chronic diseases such as diabetes and immune-modulated inflammatory conditions, including psoriasis, ulcerative colitis and rheumatoid arthritis due to their ability to provide targeted therapies. Biologics also provide safe and effective treatments for some types of cancer. One downside to biologic use is the cost of these treatments — biologics are expensive. Biosimilars are developed to mimic the safety and efficacy of originator biologics already approved for use at a reduced cost to that of the originator. Consequently, biosimilars are often seen as an answer to the problem of balancing access to biologic treatments and the costs of these medicines. As a result, governments actively promote biosimilars and biosimilar development to facilitate the cost savings biosimilars can achieve.

More specifically, this thesis examines the information exchange between originator manufacturers and biosimilar manufacturers related to patents and data exclusivity, and how the information exchange affects biosimilars and biosimilar development. In addition, the information exchange in trade secrets is important and is examined in this thesis because it creates a monopoly that is utilised by manufacturers in the pharmaceutical industry. Significantly, patents, trade secrets and data exclusivity all involve some form of information exchange between the holder of the relevant right and the pharmaceutical industry at large, including potential competitors in the pharmaceutical market.

One difficulty governments encounter in promoting biosimilars is that biosimilars are produced as intended copies of an originator biologic’s safety and efficacy. This means that in providing monopolies to originator biologics, governments may be adversely affecting the development of biosimilars. It also means that understanding how information is exchanged between originator biologics and related biosimilars is crucial. The information exchange between originator biologic manufacturers and biosimilar manufacturers is the focus of this thesis.