The Trans-Pacific Partnership (TPP) has reached agreement; consequently a major sticking point in relation to the period of data exclusivity for biological medicines has been overcome. The innovators of biological medicines were pushing for a 12 year data exclusivity period in-line with the US legislation. It is argued that this timeframe is required to recoup the major expense of funding the development of novel biological therapies. Ultimately this time period has been shortened to five to eight years. It will be good news for companies developing biosimilars and for the cost of expensive therapies to the healthcare budget of the countries included in the TPP – whether this impends future development by reducing the incentive to develop novel biologicals will remain to be seen.

The-TPP