Policies & Legislation

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.

Generics and biosimilars Initiative

News

Research

General