Policies & Legislation

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’.

Further capping of generics in Japan

Home/Policies & Legislation | Posted 29/01/2016

In a bid to increase uptake of more cost-effective drugs and to curb healthcare spending, the Japanese Government has put forward plans to price generics at half the cost of brand-name drugs from April 2016, a reduction of 10%.

Michigan introduces new biosimilars substitution bill

Home/Policies & Legislation | Posted 15/01/2016

Michigan is the latest US state to introduce 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].

Further problems for Indian manufacturing sites

Home/Policies & Legislation | Posted 11/12/2015

The US Food and Drug Administration (FDA) has written to Sandoz after identifying significant violations of current good manufacturing practice (cGMP) at two of the company’s manufacturing sites in western India, Turbhe and Kalwa. Turbhe is an Active Pharmaceutical Ingredient and Finished Dosage Manufacturing Site, Kalwha is a Finished Dosage Manufacturing Site.

New Jersey passes biosimilars substitution bill

Home/Policies & Legislation | Posted 04/12/2015

New Jersey is the latest US state to pass a law 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 [1-3].

Senator calls for FTC to investigate drugmakers for antitrust violations

Home/Policies & Legislation | Posted 06/11/2015

In light of recent drug price increases a US Senator has called on the US Federal Trade Commission (FTC) to investigate pharmaceutical companies for possible antitrust violations.

Biosimilars substitution bill becomes law in California

Home/Policies & Legislation | Posted 23/10/2015

California is the latest US state to pass a law that will allow the substitution of biosimilars at the pharmacy level. To date, 14 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1, 2].

How will biosimilars be affected by the TPP

Home/Policies & Legislation | Posted 09/10/2015

Since 2009, the US Government has been negotiating a free-trade agreement known as the Trans-Pacific Partnership (TPP) with 11 other countries across the Asia-Pacific and Latin American regions. This agreement could have major impact on the pharmaceutical market, including generics and biosimilars.

Pay-for-delay bill reintroduced

Home/Policies & Legislation | Posted 02/10/2015

On 9 September 2015, in an effort to stop pay-for-delay deals in the pharmaceutical industry, two US senators reintroduced the Preserve Access to Affordable Generics Act.

Pfizer loses UK patent protection for Lyrica in pain

Home/Policies & Legislation | Posted 25/09/2015

Pharma giant Pfizer suffered a major blow in the UK on 10 September 2015 when the High Court in London ruled that claims of patent protection for the use of its blockbuster drug Lyrica (pregabalin) as a pain treatment were invalid.

Concerns raised over CMS biosimilars reimbursement policy

Home/Policies & Legislation | Posted 19/09/2015

In July 2015, the Centers for Medicare & Medicaid Services (CMS), which provides health insurance for the elderly and children in the US, released a proposed rule for the reimbursement of biosimilars. However, various groups have raised concerns about the proposal.

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