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Policies & Legislation

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.

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.

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].

Oregon passes biosimilars substitution law

Oregon is the latest US state to pass a law 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].

Kentucky Senate passes biosimilars substitution bill

The Kentucky Senate is the latest US state to pass a bill that will allow the substitution of biosimilars at the pharmacy level. To date, 15 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1-4].

UK’s competition authority fines GSK for pay-for-delay

The UK’s Competition and Markets Authority (CMA) announced on 12 February 2016 that it had fined GlaxoSmithKline (GSK) GBP 37.6 million for anticompetitive conduct and agreements in relation to the supply of paroxetine.

Obama budget aims to increase use of generics and biosimilars

President Obama has revealed plans to increase the use of generics and biosimilars in his fiscal year 2017 budget proposal.

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