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Policies & Legislation

US Senate revives the CREATES Act

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

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

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

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.

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