Policies & Legislation

Canadian health committee proposes National Pharmacare programme

Home/Policies & Legislation | Posted 04/05/2018

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

Home/Policies & Legislation | Posted 27/04/2018

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

Home/Policies & Legislation | Posted 13/04/2018

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 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

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.

Application fees increase for prescription drugs

Home/Policies & Legislation | Posted 06/10/2017

US Food and Drug Administration (FDA) application fees for prescription drug approvals are to increase by almost 20% for FY2018, beginning from October 2017. Biosimilar user fees however will decrease.

Ireland consults on National Biosimilar Medicines Policy

Home/Policies & Legislation | Posted 08/09/2017

Ireland’s Department of Health (DoH) has begun a consultation on its biosimilars policy amid criticism from the country’s pharma industry.

FDA user fee reauthorization bill passes US House of Representatives

Home/Policies & Legislation | Posted 11/08/2017

The US House of Representatives passed a bill on 12 July 2017 reauthorizing the US Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee programmes.

US states progress drug-pricing legislation

Home/Policies & Legislation | Posted 14/07/2017

With attention being increasingly focussed on the price of drugs in the US, and with federal action on drug prices and cost transparency having stalled in Congress, several states have moved forward with their own legislation.

Quebec hopes to save millions by tendering for generics

Home/Policies & Legislation | Posted 07/07/2017

The Health Ministry in Quebec, Canada is launching a tender process for generics in an attempt to save millions of dollars. It is hoped that the new system will make medication cheaper for patients and save taxpayers CA$300 million per year.

EMA launches new EudraVigilance system for adverse reactions

Home/Policies & Legislation | Posted 30/06/2017

The European Medicines Agency (EMA) announced that it will launch a ‘new and improved version of EudraVigilance’ in November 2017, which will contain enhancements for reporting and analysing suspected adverse reactions.

US Senate revives the CREATES Act

Home/Policies & Legislation | Posted 23/06/2017

The US Senate and House Judiciary Committees have reintroduced legislation to tackle anticompetitive behaviour that delays the market entry of more affordable generic drugs.

Notice can be given before FDA approves biosimilar

Home/Policies & Legislation | Posted 16/06/2017

In a landmark decision by the US Supreme Court, biosimilars makers will be able to give notice to the originator manufacturer before the US Food and Drug Administration (FDA) has given final approval of the biosimilar.

Generics association recommends FDA regulation changes

Home/Policies & Legislation | Posted 09/06/2017

The Association for Accessible Medicines (AAM) has recommended five changes to US Food and Drug Administration (FDA) regulation, including allowing abbreviated new drug application (ANDA) sponsors the same rights as those for non-generic drugs.

Lawmakers urge CMS to reverse its biosimilars policy

Home/Policies & Legislation | Posted 26/05/2017

Senator Pat Roberts and Representatives Joe Barton and Anna Eshoo, along with a delegation of 52 House Members and nine Senators, have asked the Centers for Medicare & Medicaid Services (CMS) to reverse its biosimilars policy.

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