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FDA hearing on biosimilars: focus on characterisation and clinical trials

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].

Australian guidelines for generics

Last update: 1 July 2011

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

Japanese guidelines for generics

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].

US biosimilars pathway unlikely to be used

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.

Regulatory recommendations for biosimilars in the EU

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).

Saudi Arabian guidelines for biosimilars

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

Saudi Arabian guidelines for generics

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

FDA to release guidance on generic tablet size

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.

FDA issues new bioequivalence guidance for generics

In May 2011, the FDA issued new guidance for the submission of summary bioequivalence data for abbreviated new drug applications (ANDAs). This new guidance means that all bioequivalence data will now have to be submitted, including failed studies.

EMA, FDA and TGA joint GMP inspection programme

On 27 April 2011, the FDA announced that it is working with the EMA and Australia’s Therapeutic Goods Administration (TGA) to finalise a permanent pilot programme for joint good manufacturing practice (GMP) inspections at active pharmaceutical ingredient (API) manufacturing facilities.

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