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Policies & Legislation

Lawmakers urge CMS to reverse its biosimilars policy

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.

US introduces two new bills to promote generics

The Fair Access Safety and Timely Generics Act has been reintroduced to congress, promising to save the US billions of dollars each year, while California has introduced a bill that would ban the use of coupons for prescription drugs where a cheaper alternative exists.

How will the timing of BPCI Act 180-day notice affect biosimilars?

On 26 April 2017, the US Supreme Court heard oral arguments in Amgen vs Sandoz. The case has come to the Supreme Court after the Court of Appeals for the Federal Circuit made the controversial ruling that the so-called ‘patent dance’ was optional, but also that the 180-day notice could only be given after the 12-year exclusivity period ended.

Maryland has increased power over drug prices

The US Food and Drug Administration (FDA) announced on 2 March 2017 that the state of Maryland General Assembly was considering two bills that would require pharmaceutical companies to notify the state ahead of drug price increases. On 20 March 2017, one of these bills that sets out to ban excessive price increases for generics and off-patent drugs, was passed. In the US, legislation related to pharmaceuticals can vary across states [1].

UK authority accuses Actavis UK and Concordia of illegal agreement

The UK’s Competition and Markets Authority (CMA) alleged that pharmaceutical companies, Actavis UK and Concordia, entered into illegal agreements that allowed them to increase and maintain high prices of hydrocortisone tablets. 

India and Argentina call for hepatitis C generics

The high prices of hepatitis C drugs push the need for more generic versions to be approved worldwide. On 13 February 2017, Médecins Sans Frontières (MSF, Doctors Without Borders) reported that organizations in India and Argentina filed cases against the patents of certain hepatitis C drugs. 

EMA and FDA to recognize GMP inspections

European Union (EU) and US regulators have agreed to recognize inspections of drugmakers in Europe and the US.

Ireland to publish biosimilars report

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

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

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

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