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Policies & Legislation

China introduces new policy to boost generics

The State Council, China’s cabinet, unveiled a new policy whereby some generics manufacturers could qualify for a ‘high-tech enterprise’ designation that comes with a 15% corporate tax rate, compared to the 25% rate for other companies.

Canadian health committee proposes National Pharmacare programme

On 19 April 2018, Canada’s Standing Committee on Health released Pharmacare Now: Prescription Medicine Coverage for All Canadians, a report advocating the establishment of a national pharmacare programme, i.e. a publicly funded prescription drug coverage programme for all Canadians.

Oregon introduces pricing transparency bill

The US State of Oregon has signed a new bill into law that requires drugmakers to provide data justifying price hikes.

Three US states pass biosimilar substitution bills

The US Food and Drug Administration (FDA) gave marketing authorization to its first biosimilar in March 2015 [1]. To date, FDA has approved nine biosimilars and two follow-on biologicals [2]. All the products approved so far have been approved as biosimilars, not as interchangeable products. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

Green Shield Canada preferentially lists biosimilars

Canadian not-for-profit healthcare benefits specialist, Green Shield Canada (GSC), announced in February 2018 that it was ‘the first major benefits carrier to preferentially list biosimilars’.

US introduces bill to close drug patent loophole

The Preserving Access to Cost-Effective Drugs (PACED) Act was introduced to the US Congress on 7 March 2018.

Michigan latest state to pass biosimilars substitution law

The US Food and Drug Administration (FDA) gave marketing authorization to its first biosimilar in March 2015 [1]. To date, FDA has approved nine biosimilars [2]. All the products approved so far have been approved as biosimilars, not as interchangeable products. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

Ireland’s National Biosimilar Medicines Policy aims to increase biosimilars use

Minister of State for Ireland’s Department of Health (DoH), Jim Daly, discussed Ireland’s National Biosimilar Medicines Policy at the BioPharma Ambition Conference, which was held on 21−22 February 2018 in Dublin, Ireland.

Comments on TGA’s modified approach to naming biologicals

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), opened a consultation on how to name biologicals in July 2017. It has now received comments on its proposals to expand the information offered in its current naming system for biologicals.

France aims to reach 80% biosimilar penetration by 2022

In the coming years France intends to promote the use of biosimilars and is aiming to reach 80% biosimilar penetration by 2022.

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