Guidelines

A 2-day public meeting was held by the FDA on 2–3 October 2010 at Silver Spring, Maryland, USA, in order to obtain input on specific issues and challenges associated with the implementation of a biosimilars pathway as part of the BPCI Act. The discussions at the meeting focussed on the challenges associated with characterisation of such complex molecules and what clinical trials would be appropriate [1].

Last update: 1 July 2011

The regulatory body for therapeutic goods in Australia is the Therapeutic Goods Administration (TGA).

Last update: 1 July 2011

The Ministry for Health Labour and Welfare (MHLW) is the regulatory body in Japan responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Japan and makes the decision on approval of drugs [1].

The regulatory body for therapeutic goods in Australia is the Therapeutic Goods Administration (TGA).

Healthcare reform in the US was brought into force by the Patient Protection and Affordable Care Act (amended by the Health Care and Education Reconciliation Act) and was signed into law on 23 March 2010 by President Barack Obama.

The regulatory body for approval of medicines in the EU is the EMA.

The EU has developed a general legal pathway, and the EMA has developed regulatory guidelines, for the approval of biosimilars (see below).

The Saudi Food and Drug Authority (SFDA) is the authority that oversees all drug manufacturing, trade, and registration in Saudi Arabia.

The Saudi Food and Drug Authority (SFDA) is the authority that oversees all drug manufacturing, trade and registration in Saudi Arabia.

Last update: 1 August 2011

The regulatory body for approval of medicines in the US is the FDA.

The FDA hopes to release guidance in the next few months to help generic drug makers understand how big or small their tablet or capsule can be compared to the branded equivalent, an agency official said.