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Policies & Legislation

US health insurance CMS outlines biosimilar policy

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

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

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

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

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

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

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

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

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

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.

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