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Policies & Legislation

Epileptic V16F10

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%.

CML Bcrablmet V17A13

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%.

Samsung Bioepis Engineers V16K25LB R

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).

Pay for Delay DrugsMoneyGeneric V13F21

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.

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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.

Imatinib V13D12

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%.

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FDA and industry agree on terms of GDUFA II reauthorization

Home/Policies & Legislation | Posted 07/10/2016

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.

Pay for Delay V13C29

EU upholds decision to fine Lundbeck for violating competition law

Home/Policies & Legislation | Posted 30/09/2016

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.

Health Budget 3

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

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

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.

pill bottles V14K20

FDA lowers fees for generic drug applications

Home/Policies & Legislation | Posted 02/09/2016

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.

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

Home/Policies & Legislation | Posted 26/08/2016

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.

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New proposed bipartisan legislation would cut biologicals exclusivity to seven years

Home/Policies & Legislation | Posted 05/08/2016

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.

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New bill would stop brand-name pharma restricting drug samples

Home/Policies & Legislation | Posted 01/07/2016

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.

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GPhA raises concerns over CMS biosimilars reimbursement policy

Home/Policies & Legislation | Posted 17/06/2016

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.

Pharmacovigilance V13F21

The Netherlands to track switching of biologicals

Home/Policies & Legislation | Posted 10/06/2016

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.

Generic Brand Name V13C01

Colombia fighting to break Glivec monopoly

Home/Policies & Legislation | Posted 03/06/2016

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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China introduces new quality and efficacy requirements for generics

Home/Policies & Legislation | Posted 06/05/2016

The Chinese Food and Drug Administration (CFDA) has announced that generics in China must show bioequivalence to the originator reference product and has prohibited the use of locally made generics as reference products.

User Fee V13H23

Industry calls for generics user fees to be reduced

Home/Policies & Legislation | Posted 27/05/2016

Generics makers and industry groups have commented on the Generic Drug User Fee Amendments (GDUFA) reauthorization, calling for lower user fees and greater transparency in the review process.

Substitution V13F14

US state legislation on biosimilars substitution

Home/Policies & Legislation | Posted 11/10/2013

Despite the fact that the US Food and Drug Administration (FDA) has yet to receive a biosimilars application, many US states have been considering legislation on biosimilars substitution [1].

Regulation V13H16

California Assembly passes biosimilars substitution bill

Home/Policies & Legislation | Posted 13/09/2013

California has taken a step closer to adopting legislation which would authorize pharmacists to substitute an FDA-approved biosimilars for their reference biologicals with a notification to prescriber within five days.