Policies & Legislation

US patent office rules in Biogen’s favour on Tecfidera

Home/Policies & Legislation | Posted 28/02/2020

Biogen has won a patent challenge from Mylan over multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate).

US-Mexico-Canada agreement to benefit generics makers

Home/Policies & Legislation | Posted 21/02/2020

The amended United States-Mexico-Canada Agreement (USMCA) will benefit biosimilar and generic drug companies through changes to patent protection for originator drugs.

European Court of Justice backs UK in pay-for-delay fine against GSK

Home/Policies & Legislation | Posted 14/02/2020

The European Court of Justice has backed an earlier decision by the UK financial regulator, the Competition and Markets Authority (CMA), to fine pharma giant GlaxoSmithKline (GSK) in connection with ‘pay for delay’ deals for one of its off-patent medications.

New pricing system for drugs in Russia

Home/Policies & Legislation | Posted 07/02/2020

The Russian Government has passed a decree mandating ceiling prices for drugs on the country’s essential drugs list.

Chemically synthesized polypeptides to use biosimilars pathway

Home/Policies & Legislation | Posted 31/01/2020

The US Food and Drug Administration (FDA) is supporting a change in the government spending bill that will allow for chemically synthesized polypeptides to also be classified as biologicals.

US government department proposes rule to lower drug prices for its citizens

Home/Policies & Legislation | Posted 24/01/2020

The US Department of Health and Human Services (HHS) announced a string of changes in November 2019, including a proposal to lower drug prices for US citizens based on Trump’s ‘most favored nation’ approach.

US and EU sign milestone mutual recognition agreement

Home/Policies & Legislation | Posted 17/01/2020

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have signed a historic mutual recognition agreement which means the US will now recognize the good manufacturing practice (GMP) inspections of all EU Member States, and vice versa.

UnitedHealthcare sues generics manufacturers for price fixing

Home/Policies & Legislation | Posted 10/01/2020

US health insurance giant UnitedHealthcare has filed a lawsuit against 25 generic drugs manufacturers, accusing them of scheming to increase the prices of over 100 different drugs.

Bill to stop misuse of Citizen Petitions advances in the House

Home/Policies & Legislation | Posted 13/12/2019

On 13 November 2019, the House Energy and Commerce’s health subcommittee unanimously advanced a bipartisan bill aimed at preventing companies from using citizen petitions to delay the approval of generics.

Concerns raised as Canada’s Alberta plans to switch patients to biosimilars

Home/Policies & Legislation | Posted 22/11/2019

Canada’s province of Alberta is planning to stop coverage of originator biologicals and switch patients to biosimilars for certain indications.

US Senators reveal plans to lower drug prices

Home/Policies & Legislation | Posted 08/11/2019

The House Ways and Means Committee have approved Speaker Nancy Pelosi’s drug pricing bill, while Democratic nominee Pete Buttigieg has disclosed his own drug pricing plan that would impose penalties on ‘worst offender’ pharmaceutical companies.

Canada amends its drug pricing regulations

Home/Policies & Legislation | Posted 25/10/2019

The Canadian Government has released final amendments to its Patented Medicines Regulations. The amendments, according to the Canadian Government, represent ‘the most significant reforms to the regulations since their introduction in 1987’ and are also a significant departure from the existing framework.

A call to end US drug pricing games

Home/Policies & Legislation | Posted 27/09/2019

In a modern world dominated by personal choice, we still lack choice when it comes to health care. In the US, pharmaceutical companies play a drug pricing game that prevents low-cost medicines from being easily accessed by patients. In a commentary published in August 2019, Kathy Oubre, Chief Operations Officer of Pontchartrain Cancer Center in the US, outlined the details of drug pricing issues.

China eases generic medicine import laws

Home/Policies & Legislation | Posted 20/09/2019

China has revised its drug administration laws to allow the import and sale of small quantities of generic drugs which are not approved in China.

Praise for Canada’s BC after it adopts biosimilar transitioning policy

Home/Policies & Legislation | Posted 06/09/2019

The Canadian Biosimilars Forum and Green Shield Canada have publicly commended the government of the province of British Columbia (BC) for announcing that it will implement biosimilar transitioning [1]. Here, patients will transition in a controlled manner from using a reference biological drug to its biosimilar. In their announcement, the Forum believes that BC will make big savings that will allow increased access to existing therapies and faster access to new medicines.

China audits drug companies

Home/Policies & Legislation | Posted 23/08/2019

In June and July 2019, China embarked on an audit of 77 major pharmaceutical companies, including the local arms of Sanofi, Eli Lilly & Co and Bristol-Myers Squibb Co. This action was undertaken after one of its largest listed drug manufacturers overstated its cash position by US$4.3 billion. The announcement called an index of healthcare companies traded in Shanghai and Shenzhen to fall by 1.8%.

IPRP expands and all EU Member States now included in EU-US MRA

Home/Policies & Legislation | Posted 16/08/2019

During the June 2019 International Pharmaceutical Regulators Programme (IPRP) management committee meeting in Amsterdam, The Netherlands, it was announced that Iran’s National Regulatory Authority (NRA) and Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT – Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) have joined the IPRP. There are now 26 members of IPRP.

Bill introduced in US to cut insulin prices

Home/Policies & Legislation | Posted 09/08/2019

Co-Chair of the Senate Diabetes Caucus, Senator Jeanne Shaheen, announced on 22 July 2019 the introduction of new legislation to combat rising insulin prices.

Bipartisan bill aims to reduce healthcare costs in the US

Home/Policies & Legislation | Posted 02/08/2019

Senators Lamar Alexander and Patty Murray recently introduced the ‘Lower Health Care Costs Act of 2019’. The bipartisan bill includes 54 different proposals from 65 senators (36 Democrats and 29 Republicans), all aimed at lowering the cost of health care.

US FDA acts to improve transparency and predictability for new generics applications

Home/Policies & Legislation | Posted 26/07/2019

On 18 June 2019, the US Food and Drug Administration (FDA) released a ‘Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high quality, lower cost generic drugs’. Here, the agency outlines that, to facilitate American patients’ access to lower-cost generic medicines, they are taking steps to enhance and streamline the development and approval process of high quality generic drugs.

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