Policies & Legislation

Green Shield Canada preferentially lists biosimilars

Home/Policies & Legislation | Posted 30/03/2018

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

Home/Policies & Legislation | Posted 23/03/2018

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

Home/Policies & Legislation | Posted 16/03/2018

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

Home/Policies & Legislation | Posted 09/03/2018

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

Home/Policies & Legislation | Posted 09/02/2018

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

Home/Policies & Legislation | Posted 26/01/2018

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

Physicians urge CMS to adopt unique billing codes for biosimilars

Home/Policies & Legislation | Posted 10/11/2017

On 11 September 2017, groups representing physicians in the US commented on the biosimilar reimbursement policy of the Centers for Medicare & Medicaid Services (CMS). The six groups, which represent a broad spectrum of physicians who prescribe biologicals, have urged the CMS to revise its policy of assigning a single code to all biosimilars. Instead they urge the CMS to adopt unique Healthcare Common Procedure Coding System (HCPCS) billing codes, otherwise known as J‑Codes.