Policies & Legislation

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.

FDA issues more warnings to Indian firms

Home/Policies & Legislation | Posted 27/09/2013

The FDA is keeping up its policy of being tough on foreign manufacturers. In its latest action the agency has issued warnings to Indian drugmakers Posh Chemicals and Promed Exports for good manufacturing practice (GMP) violations.

FAST generics act re-introduced to increase generics competition

Home/Policies & Legislation | Posted 21/08/2015

On 18 June 2015, US lawmakers Steve Stivers and Peter Welch re-introduced the Fair Access for Safe and Timely (FAST) Generics Act to increase consumer access to generics, boost market competition and ultimately save consumers money.

EU stands by call for Ireland to reduce drug prices

Home/Policies & Legislation | Posted 14/08/2015

The European Commission (EC) is standing by its call for Ireland to reduce spending on medicines in the country, despite objections from originator companies.

WHO issues draft proposal for its biological qualifier

Home/Policies & Legislation | Posted 07/08/2015

The World Health Organization (WHO) first introduced the concept of a biological qualifier (BQ) for naming biologicals back in 2014. Now the body has issued a draft proposal covering the issue of how to name biologicals, including biosimilars.

Biosimilars substitution bill become law in Texas

Home/Policies & Legislation | Posted 03/07/2015

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

Biosimilars substitution bills become law in four US states

Home/Policies & Legislation | Posted 19/06/2015

The latest states to enact laws that allow the substitution of biosimilars at the pharmacy level include Georgia, North Carolina, Tennessee and Washington.

EMA to hold webinar on publication of clinical trials data

Home/Policies & Legislation | Posted 12/06/2015

The European Medicines Agency (EMA) has announced that it will hold a webinar on its policy concerning the publication of clinical trials data.

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.

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