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Policies & Legislation

FDA and industry agree on terms of GDUFA II reauthorization

According to minutes from the US Food and Drug Administration (FDA)–Industry Generic Drug User Fee Amendments (GDUFA) Reauthorization Meeting, held on 24 August 2016, FDA and industry have agreed on the terms of a GDUFA II reauthorization package and negotiations have concluded.

EU upholds decision to fine Lundbeck for violating competition law

Lundbeck’s appeal of a 2013 decision to fine the company over Euros 90 million for ‘pay-to-delay’ deals on its blockbuster anti-depressant Cipramil (citalopram) has been rejected by European Union (EU) courts.

Australia cuts prices of more than 2,000 brand-name drugs

Australia’s Department of Health announced on 4 September 2016 that it would be reducing the cost of more than 2,000 brand-name drugs, some by 50% or more.

FDA lowers fees for generic drug applications

An expected increase in generic drug submissions has prompted the US Food and Drug Administration (FDA) to lower its fees for abbreviated new drug applications (ANDA) and prior approval supplements (PAS). The changes will come into effect on 1 October 2016.

Mylan gives up two generic drugs to allow for acquisition of Meda

US-based generics manufacturer, Mylan, has divested the rights to two generic drugs. This is in accordance with the Federal Trade Commission‘s (FTC) demands and will allow Mylan to acquire the Swedish pharmaceutical company Meda.

New proposed bipartisan legislation would cut biologicals exclusivity to seven years

Back in 2009, President Barack Obama’s government pledged to reduce the cost of biosimilar drugs for consumers and the time taken for those drugs to reach market in an effort to cut healthcare spending, but little has been achieved to date.

New bill would stop brand-name pharma restricting drug samples

A new Senate bill would stop brand-name drugmakers from blocking generics competition by closing regulatory loopholes preventing generics makers from obtaining samples of the reference materials needed to test candidate generics and biosimilars.

GPhA raises concerns over CMS biosimilars reimbursement policy

The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council have raised concerns that the Centers for Medicare & Medicaid Services (CMS) proposed demonstration to revamp how Part B pays for prescription drugs will ‘erode the economic incentives that drive the US healthcare system to lower-cost therapeutic alternatives’, especially for biosimilars.

The Netherlands to track switching of biologicals

In response to an expected increase in the use of biosimilars in the country, The Netherlands Minister of Health, Edith Schippers, announced on 19 May 2016 the set-up of a national system to monitor the safety of biologicals.

Colombia fighting to break Glivec monopoly

Colombia has appealed to the World Health Organization (WHO) in an attempt to break the monopoly Swiss pharma giant Novartis has for its blockbuster cancer drug Glivec (imatinib) in the country.

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