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Policies & Legislation

New chemical entities added to ACSS work-sharing pilot

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA) announced on 17 April 2018 that it had established a new chemical entity work-sharing pilot with Health Canada.

Biosimilars substitution bill becomes law in South Dakota

The latest state to enact a law that allows the substitution of biosimilars at the pharmacy level is South Dakota. The signing of the bill marks the first biologicals substitution bill in 2018 to be signed into law.

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.

CFDA to come under national market supervision administration

A sweeping government restructuring plan was approved by China’s National People’s Congress on 17 March 2018. The reorganization will see China’s drug regulator, the China Food and Drug Administration (CFDA), merged into an overarching market supervision administration.

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.