Policies & Legislation

Mylan gives up two generic drugs to allow for acquisition of Meda

Home/Policies & Legislation | Posted 26/08/2016

US-based generics manufacturer, Mylan, has divested the rights to two generic drugs. This is in accordance with the Federal Trade Commission‘s (FTC) demands and will allow Mylan to acquire the Swedish pharmaceutical company Meda.

New proposed bipartisan legislation would cut biologicals exclusivity to seven years

Home/Policies & Legislation | Posted 05/08/2016

Back in 2009, President Barack Obama’s government pledged to reduce the cost of biosimilar drugs for consumers and the time taken for those drugs to reach market in an effort to cut healthcare spending, but little has been achieved to date.

New bill would stop brand-name pharma restricting drug samples

Home/Policies & Legislation | Posted 01/07/2016

A new Senate bill would stop brand-name drugmakers from blocking generics competition by closing regulatory loopholes preventing generics makers from obtaining samples of the reference materials needed to test candidate generics and biosimilars.

GPhA raises concerns over CMS biosimilars reimbursement policy

Home/Policies & Legislation | Posted 17/06/2016

The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council have raised concerns that the Centers for Medicare & Medicaid Services (CMS) proposed demonstration to revamp how Part B pays for prescription drugs will ‘erode the economic incentives that drive the US healthcare system to lower-cost therapeutic alternatives’, especially for biosimilars.

The Netherlands to track switching of biologicals

Home/Policies & Legislation | Posted 10/06/2016

In response to an expected increase in the use of biosimilars in the country, The Netherlands Minister of Health, Edith Schippers, announced on 19 May 2016 the set-up of a national system to monitor the safety of biologicals.

Colombia fighting to break Glivec monopoly

Home/Policies & Legislation | Posted 03/06/2016

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

Home/Policies & Legislation | Posted 06/05/2016

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

Home/Policies & Legislation | Posted 27/05/2016

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

Home/Policies & Legislation | Posted 11/10/2013

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

Home/Policies & Legislation | Posted 13/09/2013

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

Home/Policies & Legislation | Posted 18/10/2013

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

Home/Policies & Legislation | Posted 29/04/2016

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

Home/Policies & Legislation | Posted 22/04/2016

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

Home/Policies & Legislation | Posted 15/04/2016

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

Home/Policies & Legislation | Posted 01/04/2016

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

Home/Policies & Legislation | Posted 18/03/2016

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

Home/Policies & Legislation | Posted 11/03/2016

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

Home/Policies & Legislation | Posted 11/03/2016

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

Home/Policies & Legislation | Posted 04/03/2016

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

Biosimilars in UK gain NICE recommendation

Home/Policies & Legislation | Posted 05/02/2016

Biosimilars may be set to increase their market share in the UK after the country’s healthcare cost watchdog recommended that rheumatoid arthritis patients indicated for treatment with biologicals should ‘start treatment with the least expensive drug’.

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