Policies & Legislation

Finnish drug regulator recommends interchangeability of biosimilars

Home/Policies & Legislation | Posted 29/05/2015

The Finnish Medicines Agency, Fimea, announced on 22 May 2015 that it was recommending the interchangeability of biosimilars for their reference biologicals.

US generics manufacturers renew calls for labelling revisions

Home/Policies & Legislation | Posted 22/05/2015

The Generic Pharmaceutical Association (GPhA) has stepped up pressure on the US Food and Drug Administration (FDA) to update its proposed generics labelling requirements. According to GPhA, FDA should adopt the joint alternative proposal known as the Expedited Agency Review (EAR) put forward with the Pharmaceutical Research and Manufacturers of America (PhRMA).

Alternative proposal for generics labelling

Home/Policies & Legislation | Posted 15/05/2015

Consumer and patient advocacy groups clashed with economists and generics makers at the US Food and Drug Administration’s (FDA) public hearing over the agency’s proposed rule to allow generics makers to change their labels independently.

US health insurance CMS outlines biosimilar policy

Home/Policies & Legislation | Posted 27/04/2015

The Centers for Medicare & Medicaid Services (CMS), which provides health insurance for the elderly and children in the US, has issued three biosimilar reimbursement documents. The documents cover Medicare Part B, Part D and Medicaid and aim to remove incentives from physicians to prescribe more costly brand-name originator biologicals rather than biosimilars.

More US state legislation on biosimilars substitution

Home/Policies & Legislation | Posted 17/04/2015

The US Food and Drug Administration (FDA) gave marketing authorization to its first biosimilar in March 2015 [1]. In anticipation of such an approval, many US states are considering, or have introduced, laws related to the substitution of biosimilars at the pharmacy level [2]. The latest states to be considering legislation which will allow the substitution of biosimilars at the pharmacy level include Colorado, Georgia, Idaho, Maryland, New Jersey, North Carolina, Tennessee, Texas and Utah.

Drug manufacturers call for revision to FDA safety labelling rule

Home/Policies & Legislation | Posted 27/03/2015

Two national agencies representing manufacturers and distributors of generics and biopharmaceuticals in the US are calling on the US Food and Drug Administration (FDA) to re-write its proposed rule on medicines safety labelling.

California and Illinois consider biosimilar substitution bills

Home/Policies & Legislation | Posted 20/03/2015

In the ongoing saga in the US over biosimilars substitution, California and Illinois are the latest states to be considering legislation which will allow the substitution of biosimilars at the pharmacy level.

EMA’s clinical transparency rules come under fire

Home/Policies & Legislation | Posted 06/03/2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has once again questioned the transparency of the European Medicines Agency’s (EMA) clinical trials database.

FDA re-opens comment period on generics labelling rule

Home/Policies & Legislation | Posted 27/02/2015

In a Federal Register notice published on 18 February 2014 the US Food and Drug Administration (FDA) announced that it will carry out a public meeting and re-open the comment period on its proposed rule allowing generics makers to change their labelling.

EMA explains redaction of AbbVie’s data

Home/Policies & Legislation | Posted 13/02/2015

The European Medicines Agency (EMA) has been criticized for the way it has implemented new European transparency rules for pharmaceuticals and in particular for its redaction of clinical study reports for AbbVie’s arthritis blockbuster Humira (adalimumab) [1]. In response to this criticism, EMA has published a ‘detailed response’ in which the agency ‘explains its redaction rules’.

EMA recommends suspending generics from GVK Bio

Home/Policies & Legislation | Posted 06/02/2015

On 23 January 2015, the European Medicines Agency (EMA) recommended that generics medicines for which authorization in the European Union (EU) was primarily based on clinical studies conducted at India-based contract research organization (CRO) GVK Biosciences (GVK Bio) should be suspended.

EMA to collaborate with other agencies on generics

Home/Policies & Legislation | Posted 30/01/2015

The European Medicines Agency (EMA) announced on 19 January 2015 its plans to share assessments reports for generics with regulators outside the European Union (EU).

Compromise reached on US legislation on biosimilars substitution

Home/Policies & Legislation | Posted 16/01/2015

Biologicals companies, including Amgen, Actavis, Sandoz, Hospira and Genentech, and the Generic Pharmaceutical Association (GPhA) have agreed to support compromise automatic substitution legislation that would allow interchangeable biologicals to be automatically substituted at the pharmacy.

UK outlines process for developing biosimilars guidances

Home/Policies & Legislation | Posted 23/01/2015

In response to the increasing availability and use of biosimilars by the UK’s National Health Service (NHS), the country’s healthcare watchdog, the National Institute for Health and Care Excellence (NICE), has updated its methods for providing guidance and advice on biosimilars.

Generics makers to be penalized for huge price hikes

Home/Policies & Legislation | Posted 09/01/2015

Legislation was introduced into the US Senate on 20 November 2014 that, if passed, would require generics makers that increase prices dramatically to pay a rebate to Medicaid*.

Trade groups comment on China’s biosimilars guidance

Home/Policies & Legislation | Posted 12/12/2014

Trade groups: the Biotechnology Industry Organization (BIO) and the R&D-based Pharmaceutical Association Committee in China (RDPAC), both of which represent originator biologicals companies, have each asked the China Food and Drug Administration (CFDA) to modify its draft biosimilars guidance.

FDA delays finalization of generics labelling rule

Home/Policies & Legislation | Posted 05/12/2014

The US Food and Drug Administration (FDA) is delaying the issue of its controversial rule on generics labelling changes, which was expected to be finalized in December 2014, until autumn 2015.

Developments in the US over state biosimilars substitution rules

Home/Policies & Legislation | Posted 28/11/2014

The US Food and Drug Administration (FDA) is still to finalize guidelines regarding biosimilars and has yet to approve a biosimilar. However, despite this fact, many US states are considering, or have introduced, laws related to the substitution of biosimilars at the pharmacy level [1]. The latest US states to weigh in on the biosimilars substitution debate are Idaho and Pennsylvania.

EMA criticized for redaction of AbbVie’s data

Home/Policies & Legislation | Posted 21/11/2014

The European Medicines Agency (EMA) has once again come under fire for the way it is implementing new European transparency rules for pharmaceuticals. The latest criticism of EMA concerns the way the agency is redacting clinical trials data.

Another old drug to see huge price increase in the US

Home/Policies & Legislation | Posted 14/11/2014

Catalyst Pharmaceuticals (Catalyst) is preparing to increase the price of Firdapse (3,4-diaminopyridine) for the rare disorder Lambert-Eaton Myasthenic Syndrome (LEMS). This comes despite the fact that the drug’s active ingredient has been on the market in the US for more than 20 years.

India’s policies prevent secondary patenting and encourage generics

Home/Policies & Legislation | Posted 07/11/2014

Despite criticism by some of India’s policies when it comes to medicines, others see the country’s patent law and practices as favourable to public health, while still being in line with international trade and intellectual property rules.

Endo accused of Opana pay-for-delay

Home/Policies & Legislation | Posted 31/10/2014

Specialty drugmaker Endo Health Solutions (Endo) has been accused of paying Impax Laboratories (Impax) more than US$112 million to keep their generic version of its powerful painkiller, Opana ER (oxymorphone), off the market from June 2010 to January 2013.

India drops planned price caps on non-essential drugs

Home/Policies & Legislation | Posted 24/10/2014

The Indian Government has scrapped plans to extend price cuts on both generic and brand-name drugs to include ‘non-essential’ drugs.

Implications of Canadian–European Trade Agreement for generics

Home/Policies & Legislation | Posted 17/10/2014

On 26 September 2014, Canada and the European Union (EU) successfully concluded negotiations on a trade deal, which will free the movement of goods, services, investment and labour between the two regions. However, some of the provisions in the agreement have been criticized by generics makers for delaying access to medicines by having a negative effect on the generics industry in Canada.

Idaho proposes legislation on biosimilars substitution

Home/Policies & Legislation | Posted 29/08/2014

The Idaho Board of Pharmacy held a hearing on 5 and 6 August 2014 regarding proposed regulations for the treatment of biosimilars in their state.

Servier and generics makers fined for pay-for-delay

Home/Policies & Legislation | Posted 08/08/2014

French drugmaker Les Laboratoires Servier (Servier) and five generics companies have been fined a total of Euros 427 million by the European Commission due to practices delaying the entry of generic perindopril, a medicine to treat high blood pressure.

EC expected to dish out more pay-for-delay fines

Home/Policies & Legislation | Posted 01/08/2014

The European Commission (EC) is planning to fine French drugmaker Les Laboratoires Servier (Servier) and generics giant Teva Pharmaceutical Industries (Teva) in its latest round of investigations over so-called ‘pay-for-delay’ deals.

Companies required to update information on drugs

Home/Policies & Legislation | Posted 04/07/2014

The European Medicines Agency (EMA) announced that as of 16 June 2014 marketing authorization holders would be required to update the information on medicines authorized in the European Union.

EMA changes transparency plans to increase access to data

Home/Policies & Legislation | Posted 27/06/2014

The European Medicines Agency (EMA) has done an about-turn on its data transparency plans after the agency’s draft on the conditions of use for the EMA interface were criticized for limiting access to clinical trials data.

Massachusetts governor signs biosimilars substitution bill

Home/Policies & Legislation | Posted 27/06/2014

Massachusetts has become the latest US state to pass a law allowing substitution of a biosimilar for an originator biological, but with certain restrictions.

Court rules Canadian drug regulators cannot control generics' prices

Home/Policies & Legislation | Posted 27/06/2014

Canada’s Patented Medicine Prices Review Board (PMPRB) has been told that it has no jurisdiction over the pricing of generics.

EMA criticized for change in data transparency plans

Home/Policies & Legislation | Posted 20/06/2014

New Legislation approved by the European Parliament on 2 April 2014 aims to increase transparency with respect to clinical trials by making the results publicly available. The Clinical Trials Regulation, which is expected to take effect in 2016, will require the results of all new clinical trials to be published within a year of the trial ending. The way, however, that the European Medicines Agency (EMA) is proposing to make this data available has been criticized.

France to allow biosimilars substitution

Home/Policies & Legislation | Posted 21/02/2014

Pharmacists in France will now be allowed to substitute a biosimilar for the prescribed (reference) biological under certain conditions, including only when initiating a course of treatment and that the prescribing physician has not marked the prescription as ‘non-substitutable’.

WHO calls for better science-based regulations for biosimilars

Home/Policies & Legislation | Posted 13/06/2014

The sixty-seventh World Health Assembly (WHA) of the World Health Organization (WHO) closed on 24 May 2014, after adopting more than 20 resolutions on public health issues of global importance, one of which calls for better science-based regulations for biosimilars.

Europe–Japan cooperation on generics and biosimilars regulation

Home/Policies & Legislation | Posted 06/06/2014

Japanese and European generics groups have met to discuss increase regulatory cooperation between the two regions.

EMA and FDA report on collaborative efforts

Home/Policies & Legislation | Posted 16/05/2014

Key initiatives being undertaken between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) were discussed at a bilateral meeting which took place in London, UK, from 31 March to 1 April 2014.

Delaware passes biosimilars substitution law

Home/Policies & Legislation | Posted 25/04/2014

Delaware has become the latest US state to pass a law allowing substitution of a biosimilar for an originator biological, but with certain restrictions.

Australian price cuts make PBS affordable

Home/Policies & Legislation | Posted 11/04/2014

The price cuts for 121 medicines supplied through Australia’s Pharmaceutical Benefits Scheme (PBS) have made the PBS sustainable, according to Medicines Australia, a group that represents originator manufacturers.

Bill proposes extension of patents for new uses of biologicals

Home/Policies & Legislation | Posted 04/04/2014

A new bill, introduced in the US House of Representatives on 24 March 2014, proposes allowing patent owners to extend terms for certain biological patents if they are approved for new indications.

Indiana biosimilars substitution bill becomes law

Home/Policies & Legislation | Posted 28/03/2014

Indiana Governor Mike Pence signed into law on 25 March 2014 legislation that will allow pharmacists to substitute biosimilars that the US Federal Drug Administration (FDA) has approved as interchangeable with an originator biological under certain conditions.

Obama pushes for 7-year exclusivity for biologicals

Home/Policies & Legislation | Posted 21/03/2014

US President Barack Obama has announced proposals for fiscal year 2015 which aim to increase the availability of generics and biosimilars.

Proposal in Brazil to exempt medicines from tax

Home/Policies & Legislation | Posted 21/03/2014

The Brazilian Government announced on 9 February 2014 that it is setting up a committee to evaluate whether to exempt medicines from tax in the country.

EMA and FDA extend quality collaboration

Home/Policies & Legislation | Posted 14/03/2014

The European Medicines Agency (EMA) announced on 6 March 2014 that as of 1 April 2014 EMA and the US Food and Drug Administration (FDA) have agreed on a two-year extension of their joint pilot programme for the parallel evaluation of quality elements, known as quality-by-design (QbD), for applications submitted to both agencies.

European trade organizations worried about pharmacovigilance fees

Home/Policies & Legislation | Posted 07/03/2014

Some of Europe’s major trade associations have expressed their concerns over fees being proposed by the European Medicines Agency (EMA) as part of new European Union (EU) pharmacovigilance rules.

FDA and Health Canada streamline drug submissions

Home/Policies & Legislation | Posted 28/02/2014

The US Food and Drug Administration (FDA) and Health Canada have joined forces to launch the Common Electronic Submissions Gateway. Drug companies will be able to use the gateway to send drug authorization data online using a special dedicated channel of FDA’s existing system.

Washington State legislation on biosimilars

Home/Policies & Legislation | Posted 07/02/2014

Biologicals manufacturers represented by the Biotechnology Industry Association (BIO) and the Washington Biotechnology & Biomedical Association have welcomed proposed Washington State legislation that will support the substitution of interchangeable biological medicines.

Brazil to designate medicamentos similares as interchangeable

Home/Policies & Legislation | Posted 24/01/2014

Medicamentos similares (similar medicines) may soon be substituted with the reference drug in Brazil, under the latest initiative launched by the country’s National Health Surveillance Agency [Agência Nacional de Vigilância Sanitária, ANVISA].

EMA and FDA launch joint generics inspections

Home/Policies & Legislation | Posted 17/01/2014

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will work together to ensure the safety of generic medicines. It is hoped that streamlining the inspection process for generic drug applications will help consumers gain access to safe and effective generics.

Pennsylvania moves closer to adopting biosimilars legislation

Home/Policies & Legislation | Posted 29/11/2013

Pennsylvania has taken a step closer to adopting legislation which would authorize pharmacists to be able to substitute FDA-approved biosimilars for their reference biologicals, but with certain restrictions.

Biologicals in EU to be identified by brand names

Home/Policies & Legislation | Posted 22/02/2013

The European Commission has issued a directive, which requires biological products to be identified by brand name and not by international nonproprietary name (INN).

FDA to allow generics makers to change labelling

Home/Policies & Legislation | Posted 22/11/2013

On 8 November 2013 the US Food and Drug Administration (FDA) announced that it had published its proposed rule allowing generics makers to change their labelling in the Federal Register.

South Africa to allow parallel imports and compulsory licensing

Home/Policies & Legislation | Posted 15/11/2013

Just two months after releasing a draft policy on intellectual property, South Africa has announced that it will also amend its patent legislation to allow parallel imports and compulsory licensing.

FDA issues first warning letter for unpaid generics user fees

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

In what appears to be the first of its kind, FDA has warned CPM Contract Pharma (CPM) for failing to self identify and pay its generic drug user fees.

India’s drug regulator finds no problem at Ranbaxy sites

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

India’s drug regulator has found no major discrepancies at the Mohali manufacturing unit of Ranbaxy Laboratories (Ranbaxy) in contrast to FDA findings.

Health Canada announces plans to tackle drug shortages

Home/Policies & Legislation | Posted 20/09/2013

Health Canada announced on 13 September 2013 plans, which it is hoped will help to address problems the country has been having with shortages of drugs in Canada.

South Africa introduces new patent policy

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

South Africa has become the latest country to examine its patent laws with a view to curbing patent evergreening and increasing production of generics.

Lundbeck fights back against EU pay-for-delay fine

Home/Policies & Legislation | Posted 06/09/2013

Lundbeck announced on 2 September 2013 that it had filed an appeal against the European Commission’s decision to fine the Danish pharmaceutical company, along with four generics makers for pay-for-delay deals.

India to make prescribing of generics compulsory

Home/Policies & Legislation | Posted 30/08/2013

A parliamentary panel is proposing that the Indian Government should bring in legislation that would make it compulsory for doctors to prescribe only low cost generic drugs.

New FDA requirements for generics trials

Home/Policies & Legislation | Posted 16/08/2013

As of January 2014 generics companies may be required to submit data for not just one batch, as is currently the case, but for three batches.

Generics may be allowed to change drug labelling

Home/Policies & Legislation | Posted 02/08/2013

FDA has proposed a new rule which would allow generics makers to change their labelling in the same way as brand-name manufacturers.

Fourth US state rejects law restricting biosimilar substitution

Home/Policies & Legislation | Posted 12/04/2013

Maryland has become the fourth US state to reject legislation that could restrict pharmacists’ ability to substitute cheaper biosimilars for their reference biologicals.

Lundbeck and 4 generics makers fined for pay-for-delay deals

Home/Policies & Legislation | Posted 28/06/2013

The European Commission (EC) announced on 19 June 2013 that it had fined Danish pharmaceutical company Lundbeck and four generics makers for pay-for-delay deals in Europe.

India lists API exporters with written confirmation

Home/Policies & Legislation | Posted 28/06/2013

The Indian drugs regulator has published a list of manufacturers for which it has granted written confirmation that the active pharmaceutical ingredients (APIs) comply with the European Union’s (EU’s) good manufacturing practice (GMP) requirements.

EU lists Japan as having equivalent GMP standards

Home/Policies & Legislation | Posted 21/06/2013

Japan is the latest country to join Australia and Switzerland on the European Union’s (EU’s) list of countries that comply with its good manufacturing practice (GMP) requirements.

US Supreme Court backs FTC in pay-for-delay case

Home/Policies & Legislation | Posted 21/06/2013

On 17 June 2013 the US Supreme Court ruled 5-3 in favour of the Federal Trade Commission (FTC) in the case of FTC versus Actavis with respect to reverse patent settlements or ‘pay-for-delay’, as the FTC terms these deals.

Indian Government moves closer to complying with EU API rules

Home/Policies & Legislation | Posted 14/06/2013

On 23 May 2013, the Indian Government announced that it had issued finalized guidelines for drugmakers to comply with a European Union (EU) directive on standards for import of active pharmaceutical ingredients (APIs) into the EU that takes effect on 2 July 2013.

EU to fine 9 drugmakers over pay-for-delay deals

Home/Policies & Legislation | Posted 07/06/2013

The European Commission (EC) is reportedly ready to fine Danish pharmaceutical company Lundbeck and eight generics makers over alleged pay-for-delay deals in Europe.

Ireland passes bill to encourage generics use

Home/Policies & Legislation | Posted 31/05/2013

On 22 May 2013, the Health (Pricing and Supply of Medical Goods) Bill 2012 was passed by both Houses of the Oireachtas (Irish Parliament).

India introduces new drug pricing control

Home/Policies & Legislation | Posted 31/05/2013

On 15 May 2013, India’s Directorate of Food and Drugs Administration announced the introduction of a new Drug Price Control Order (DPCO), which is expected to lead to price reductions of up to 80% in ‘essential drugs’.

Kazakhstan, Russia, Ukraine to change drug reimbursement schemes

Home/Policies & Legislation | Posted 24/05/2013

Most of the Commonwealth of Independent States (CIS) countries do not have modern drug reimbursement policies. However, recently Kazakhstan, Russia and Ukraine have all taken steps to improve their drug policies and introduce drug reimbursement schemes similar to those employed in other countries.

Australia reviews chemotherapy drug subsidies

Home/Policies & Legislation | Posted 17/05/2013

The Australian Government announced on 5 May 2013 a major review into the way chemotherapy drugs are funded.

Generics makers to self-identify for FY2014 generics fees

Home/Policies & Legislation | Posted 10/05/2013

FDA has informed generics and active pharmaceutical ingredient (API) manufacturers that they will have one month to self-identify for the generics drug user fees for fiscal year (FY) 2014.

EMA publishes concept paper on extrapolation

Home/Policies & Legislation | Posted 03/05/2013

EMA published a concept paper on extrapolation of efficacy and safety in drug development in April 2013. The publication of the concept paper comes at a time when extrapolation for biosimilars is a hot topic.

China and India still to comply with new EU API rules

Home/Policies & Legislation | Posted 29/04/2013

The European Union (EU) has introduced new rules for importing active pharmaceutical ingredients (APIs) for human use into Europe; however, two of its biggest suppliers have yet to put systems in place to comply with these new rules.

Indian high court allows sitagliptin generics

Home/Policies & Legislation | Posted 19/04/2013

In the latest development in Merck Sharp and Dohme’s (MSD’s) court case over the patent infringement of its diabetes drugs, an Indian high court has refused to grant interim relief to MSD, thus allowing generics to remain on the Indian market.

Indian Supreme Court rejects Glivec patent

Home/Policies & Legislation | Posted 12/04/2013

On 2 April 2013, the Supreme Court of India rejected drugmaker Novartis’ seven-year battle to patent its cancer drug Glivec (imatinib mesylate), ruling that the drug was not a new invention.

US FTC sides with generics makers over drug samples

Home/Policies & Legislation | Posted 05/04/2013

The US Federal Trade Commission (FTC) has come out in support of generics companies trying to get hold of brand-name drugs in order to make generic versions.

Brand-name drug and generics makers fight to save pay-for-delay

Home/Policies & Legislation | Posted 29/03/2013

Brand-name drug and generics manufacturers are joining forces to fight against the US Federal Trade Commission (FTC) in the case of reverse patent settlements or ‘pay-for-delay’, as the FTC terms these deals.

US state biosimilar substitution bill becomes law

Home/Policies & Legislation | Posted 29/03/2013

On 21 March 2013, the US State of Virginia signed into law a legislation allowing for the substitution of biosimilars, but with many restrictions, making it the first US state to introduce such legislation. Brand-name biologicals manufacturers have praised the law as putting patients first, but the generics industry has accused it of pre-empting FDA guidance.

Evergreening patents may make drugs too costly for patients in Thailand

Home/Policies & Legislation | Posted 22/03/2013

Many medicines will become too expensive for patients in Thailand in the near future if the government allows manufacturers to extend patents under the so-called ‘evergreen system’.