Policies & Legislation

Ireland to publish biosimilars report

Home/Policies & Legislation | Posted 10/03/2017

Ireland’s Minister for Health Simon Harris is to publish a consultation on biosimilars, he announced at a recent conference. The Minister discussed his hopes to increase their use and provide significant savings for the Irish healthcare budget.

British oncologists back biosimilar mAbs to treat cancer

Home/Policies & Legislation | Posted 03/03/2017

The British Oncology Pharmacy Association (BOPA) announced on 7 February 2017 the publication of its position statement and implementation guidelines on Biosimilar Monoclonal Antibodies.

World Trade Organization allows generics imports into developing countries

Home/Policies & Legislation | Posted 24/02/2017

The World Trade Organization (WTO) has amended its intellectual property agreement to allow developing countries with limited drug production abilities to import generic drugs.

US Supreme Court to review 180-day notice for biosimilars

Home/Policies & Legislation | Posted 03/02/2017

The US Supreme Court announced on 13 January 2017 that it has agreed to hear a case centred on whether biosimilar makers have to give 180 days of notification to the originator biological manufacturer before launching their biosimilar.

UK fines Pfizer and Flynn following epilepsy drug price hikes

Home/Policies & Legislation | Posted 27/01/2017

The UK Competition and Markets Authority (CMA) has fined Pfizer and Flynn Pharma a combined total of almost GBP 90 million (US$110 million) for increasing the prices of phenytoin anti-epilepsy tablets by over 2,000%.

Colombia slashes price of cancer treatment Glivec

Home/Policies & Legislation | Posted 13/01/2017

The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social, MinSalud) has unilaterally ruled to cut the price of Novartis’ blockbuster leukaemia drug, Glivec (imatinib), by 44%.

Japan joins international GMP collaboration

Home/Policies & Legislation | Posted 09/12/2016

The European Medicines Agency (EMA) announced on 25 November 2016 that it would be expanding its ongoing collaboration on good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) manufacturers to include Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

FDA amends citizen petition rules to reduce delays to generics and biosimilars

Home/Policies & Legislation | Posted 25/11/2016

The US Food and Drug Administration (FDA) has amended the requirements for filing citizen petitions and petitions for stay of action to avoid unnecessarily delaying generics or biosimilars applications.

TTIP could further delay access to generics

Home/Policies & Legislation | Posted 11/11/2016

The European Union (EU) and the US risk being locked into higher drug prices during negotiations for the Transatlantic Trade and Investment Partnership (TTIP), according to a joint report released by Health Action International (HAI), the Commons Network and Public Citizen.

Colombia to enforce declaration of public interest for Glivec

Home/Policies & Legislation | Posted 28/10/2016

Colombia’s Ministry of Health and Social Protection (MinSalud) confirmed on 14 September 2016 that it was to enforce a declaration of public interest and cut the prices for blockbuster cancer drug Glivec (imatinib) by 45%.