Policies & Legislation

China introduces new policy to boost generics

Home/Policies & Legislation | Posted 11/05/2018

The State Council, China’s cabinet, unveiled a new policy whereby some generics manufacturers could qualify for a ‘high-tech enterprise’ designation that comes with a 15% corporate tax rate, compared to the 25% rate for other companies.

Canadian health committee proposes National Pharmacare programme

Home/Policies & Legislation | Posted 04/05/2018

On 19 April 2018, Canada’s Standing Committee on Health released Pharmacare Now: Prescription Medicine Coverage for All Canadians, a report advocating the establishment of a national pharmacare programme, i.e. a publicly funded prescription drug coverage programme for all Canadians.

Oregon introduces pricing transparency bill

Home/Policies & Legislation | Posted 27/04/2018

The US State of Oregon has signed a new bill into law that requires drugmakers to provide data justifying price hikes.

Three US states pass biosimilar substitution bills

Home/Policies & Legislation | Posted 13/04/2018

The US Food and Drug Administration (FDA) gave marketing authorization to its first biosimilar in March 2015 [1]. To date, FDA has approved nine biosimilars and two follow-on biologicals [2]. All the products approved so far have been approved as biosimilars, not as interchangeable products. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

Green Shield Canada preferentially lists biosimilars

Home/Policies & Legislation | Posted 30/03/2018

Canadian not-for-profit healthcare benefits specialist, Green Shield Canada (GSC), announced in February 2018 that it was ‘the first major benefits carrier to preferentially list biosimilars’.

US introduces bill to close drug patent loophole

Home/Policies & Legislation | Posted 23/03/2018

The Preserving Access to Cost-Effective Drugs (PACED) Act was introduced to the US Congress on 7 March 2018.

Michigan latest state to pass biosimilars substitution law

Home/Policies & Legislation | Posted 16/03/2018

The US Food and Drug Administration (FDA) gave marketing authorization to its first biosimilar in March 2015 [1]. To date, FDA has approved nine biosimilars [2]. All the products approved so far have been approved as biosimilars, not as interchangeable products. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

Ireland’s National Biosimilar Medicines Policy aims to increase biosimilars use

Home/Policies & Legislation | Posted 09/03/2018

Minister of State for Ireland’s Department of Health (DoH), Jim Daly, discussed Ireland’s National Biosimilar Medicines Policy at the BioPharma Ambition Conference, which was held on 21−22 February 2018 in Dublin, Ireland.

Comments on TGA’s modified approach to naming biologicals

Home/Policies & Legislation | Posted 09/02/2018

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), opened a consultation on how to name biologicals in July 2017. It has now received comments on its proposals to expand the information offered in its current naming system for biologicals.

France aims to reach 80% biosimilar penetration by 2022

Home/Policies & Legislation | Posted 26/01/2018

In the coming years France intends to promote the use of biosimilars and is aiming to reach 80% biosimilar penetration by 2022.

Physicians urge CMS to adopt unique billing codes for biosimilars

Home/Policies & Legislation | Posted 10/11/2017

On 11 September 2017, groups representing physicians in the US commented on the biosimilar reimbursement policy of the Centers for Medicare & Medicaid Services (CMS). The six groups, which represent a broad spectrum of physicians who prescribe biologicals, have urged the CMS to revise its policy of assigning a single code to all biosimilars. Instead they urge the CMS to adopt unique Healthcare Common Procedure Coding System (HCPCS) billing codes, otherwise known as J‑Codes.

Application fees increase for prescription drugs

Home/Policies & Legislation | Posted 06/10/2017

US Food and Drug Administration (FDA) application fees for prescription drug approvals are to increase by almost 20% for FY2018, beginning from October 2017. Biosimilar user fees however will decrease.

Ireland consults on National Biosimilar Medicines Policy

Home/Policies & Legislation | Posted 08/09/2017

Ireland’s Department of Health (DoH) has begun a consultation on its biosimilars policy amid criticism from the country’s pharma industry.

FDA user fee reauthorization bill passes US House of Representatives

Home/Policies & Legislation | Posted 11/08/2017

The US House of Representatives passed a bill on 12 July 2017 reauthorizing the US Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee programmes.

US states progress drug-pricing legislation

Home/Policies & Legislation | Posted 14/07/2017

With attention being increasingly focussed on the price of drugs in the US, and with federal action on drug prices and cost transparency having stalled in Congress, several states have moved forward with their own legislation.

Quebec hopes to save millions by tendering for generics

Home/Policies & Legislation | Posted 07/07/2017

The Health Ministry in Quebec, Canada is launching a tender process for generics in an attempt to save millions of dollars. It is hoped that the new system will make medication cheaper for patients and save taxpayers CA$300 million per year.

EMA launches new EudraVigilance system for adverse reactions

Home/Policies & Legislation | Posted 30/06/2017

The European Medicines Agency (EMA) announced that it will launch a ‘new and improved version of EudraVigilance’ in November 2017, which will contain enhancements for reporting and analysing suspected adverse reactions.

US Senate revives the CREATES Act

Home/Policies & Legislation | Posted 23/06/2017

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

Home/Policies & Legislation | Posted 16/06/2017

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

Home/Policies & Legislation | Posted 09/06/2017

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

Home/Policies & Legislation | Posted 26/05/2017

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

Home/Policies & Legislation | Posted 12/05/2017

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?

Home/Policies & Legislation | Posted 04/05/2017

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

Home/Policies & Legislation | Posted 21/04/2017

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

Home/Policies & Legislation | Posted 07/04/2017

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

Home/Policies & Legislation | Posted 31/03/2017

The high prices of hepatitis C drugs push the need for more generic versions to be approved worldwide. On 13February 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

Home/Policies & Legislation | Posted 24/03/2017

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

Ireland to publish biosimilars report

Home/Policies & Legislation | Posted 10/03/2017

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

Home/Policies & Legislation | Posted 03/03/2017

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

Home/Policies & Legislation | Posted 24/02/2017

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

US Supreme Court to review 180-day notice for biosimilars

Home/Policies & Legislation | Posted 03/02/2017

The US Supreme Court announced on 13 January 2017 that it has agreed to hear a case centred on whether biosimilar makers have to give 180 days of notification to the originator biological manufacturer before launching their biosimilar.

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%.

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%.

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).

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.

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.

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%.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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].

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.

California governor vetoes biosimilars bill

Home/Policies & Legislation | Posted 18/10/2013

On 12 October 2013, California Governor Jerry Brown vetoed legislation known as SB 598, a bill that some believed would have impeded access to biosimilars.

Colombia recommends compulsory licence for Glivec

Home/Policies & Legislation | Posted 29/04/2016

A committee of the Colombian Ministry of Health and Social Protection has recommended a compulsory licence to be issued for cancer treatment Glivec (imatinib) sold by Novartis.

Australia announces price cuts for common prescription drugs

Home/Policies & Legislation | Posted 22/04/2016

As of 4 April 2016 the prices of more than 400 of Australia’s most commonly prescribed medicines, including cholesterol and high blood pressure treatments, will be reduced by as much as AU$20.

India caps prices of 530 essential drugs

Home/Policies & Legislation | Posted 15/04/2016

India has increased the number of drugs it considers ‘essential’ and therefore for which it controls the maximum retail price in the country.

Idaho governor signs biosimilars substitution bill

Home/Policies & Legislation | Posted 01/04/2016

Idaho is the latest US state to pass a bill that will allow the substitution of biosimilars at the pharmacy level. To date, 16 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1-4].

Oregon passes biosimilars substitution law

Home/Policies & Legislation | Posted 18/03/2016

Oregon is the latest US state to pass a law that will allow the substitution of biosimilars at the pharmacy level. To date, 16 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1-4].

Kentucky Senate passes biosimilars substitution bill

Home/Policies & Legislation | Posted 11/03/2016

The Kentucky Senate is the latest US state to pass a bill that will allow the substitution of biosimilars at the pharmacy level. To date, 15 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1-4].

UK’s competition authority fines GSK for pay-for-delay

Home/Policies & Legislation | Posted 11/03/2016

The UK’s Competition and Markets Authority (CMA) announced on 12 February 2016 that it had fined GlaxoSmithKline (GSK) GBP 37.6 million for anticompetitive conduct and agreements in relation to the supply of paroxetine.

Obama budget aims to increase use of generics and biosimilars

Home/Policies & Legislation | Posted 04/03/2016

President Obama has revealed plans to increase the use of generics and biosimilars in his fiscal year 2017 budget proposal.

Biosimilars in UK gain NICE recommendation

Home/Policies & Legislation | Posted 05/02/2016

Biosimilars may be set to increase their market share in the UK after the country’s healthcare cost watchdog recommended that rheumatoid arthritis patients indicated for treatment with biologicals should ‘start treatment with the least expensive drug’.

Further capping of generics in Japan

Home/Policies & Legislation | Posted 29/01/2016

In a bid to increase uptake of more cost-effective drugs and to curb healthcare spending, the Japanese Government has put forward plans to price generics at half the cost of brand-name drugs from April 2016, a reduction of 10%.

Michigan introduces new biosimilars substitution bill

Home/Policies & Legislation | Posted 15/01/2016

Michigan is the latest US state to introduce a bill that will allow the substitution of biosimilars at the pharmacy level. To date, 15 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1-4].

Further problems for Indian manufacturing sites

Home/Policies & Legislation | Posted 11/12/2015

The US Food and Drug Administration (FDA) has written to Sandoz after identifying significant violations of current good manufacturing practice (cGMP) at two of the company’s manufacturing sites in western India, Turbhe and Kalwa. Turbhe is an Active Pharmaceutical Ingredient and Finished Dosage Manufacturing Site, Kalwha is a Finished Dosage Manufacturing Site.

New Jersey passes biosimilars substitution bill

Home/Policies & Legislation | Posted 04/12/2015

New Jersey is the latest US state to pass a law that will allow the substitution of biosimilars at the pharmacy level. To date, 15 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1-3].

Senator calls for FTC to investigate drugmakers for antitrust violations

Home/Policies & Legislation | Posted 06/11/2015

In light of recent drug price increases a US Senator has called on the US Federal Trade Commission (FTC) to investigate pharmaceutical companies for possible antitrust violations.

Biosimilars substitution bill becomes law in California

Home/Policies & Legislation | Posted 23/10/2015

California is the latest US state to pass a law that will allow the substitution of biosimilars at the pharmacy level. To date, 14 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1, 2].

How will biosimilars be affected by the TPP

Home/Policies & Legislation | Posted 09/10/2015

Since 2009, the US Government has been negotiating a free-trade agreement known as the Trans-Pacific Partnership (TPP) with 11 other countries across the Asia-Pacific and Latin American regions. This agreement could have major impact on the pharmaceutical market, including generics and biosimilars.

Pay-for-delay bill reintroduced

Home/Policies & Legislation | Posted 02/10/2015

On 9 September 2015, in an effort to stop pay-for-delay deals in the pharmaceutical industry, two US senators reintroduced the Preserve Access to Affordable Generics Act.

Pfizer loses UK patent protection for Lyrica in pain

Home/Policies & Legislation | Posted 25/09/2015

Pharma giant Pfizer suffered a major blow in the UK on 10 September 2015 when the High Court in London ruled that claims of patent protection for the use of its blockbuster drug Lyrica (pregabalin) as a pain treatment were invalid.

Concerns raised over CMS biosimilars reimbursement policy

Home/Policies & Legislation | Posted 19/09/2015

In July 2015, the Centers for Medicare & Medicaid Services (CMS), which provides health insurance for the elderly and children in the US, released a proposed rule for the reimbursement of biosimilars. However, various groups have raised concerns about the proposal.

FDA issues warning letters to Indian firms

Home/Policies & Legislation | Posted 28/08/2015

The US Food and Drug Administration (FDA) is not letting up with its policy of being tough on foreign manufacturers. In its latest action the agency has issued warnings to Indian drugmakers Mylan and Mahendra Chemicals for good manufacturing practice (GMP) violations.

Canada clarifies regulatory pathway for subsequent entry low molecular weight heparins

Home/Policies & Legislation | Posted 04/10/2013

Canada’s federal department responsible for health, Health Canada, is asking drugmakers seeking approval of similar drugs containing low molecular weight heparins (LMWHs) to use the approval pathway for subsequent entry biologics (SEBs), as they are called in Canada.