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Policies & Legislation

Colombia fighting to break Glivec monopoly

Colombia has appealed to the World Health Organization (WHO) in an attempt to break the monopoly Swiss pharma giant Novartis has for its blockbuster cancer drug Glivec (imatinib) in the country.

China introduces new quality and efficacy requirements for generics

The Chinese Food and Drug Administration (CFDA) has announced that generics in China must show bioequivalence to the originator reference product and has prohibited the use of locally made generics as reference products.

Industry calls for generics user fees to be reduced

Generics makers and industry groups have commented on the Generic Drug User Fee Amendments (GDUFA) reauthorization, calling for lower user fees and greater transparency in the review process.

US state legislation on biosimilars substitution

Despite the fact that the US Food and Drug Administration (FDA) has yet to receive a biosimilars application, many US states have been considering legislation on biosimilars substitution [1].

California Assembly passes biosimilars substitution bill

California has taken a step closer to adopting legislation which would authorize pharmacists to substitute an FDA-approved biosimilars for their reference biologicals with a notification to prescriber within five days.

California governor vetoes biosimilars bill

On 12 October 2013, California Governor Jerry Brown vetoed legislation known as SB 598, a bill that some believed would have impeded access to biosimilars.

Colombia recommends compulsory licence for Glivec

A committee of the Colombian Ministry of Health and Social Protection has recommended a compulsory licence to be issued for cancer treatment Glivec (imatinib) sold by Novartis.

Australia announces price cuts for common prescription drugs

As of 4 April 2016 the prices of more than 400 of Australia’s most commonly prescribed medicines, including cholesterol and high blood pressure treatments, will be reduced by as much as AU$20.

India caps prices of 530 essential drugs

India has increased the number of drugs it considers ‘essential’ and therefore for which it controls the maximum retail price in the country.

Idaho governor signs biosimilars substitution bill

Idaho is the latest US state to pass a bill that will allow the substitution of biosimilars at the pharmacy level. To date, 16 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1-4].