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Policies & Legislation

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.

UK outlines process for developing biosimilars guidances

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

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

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

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

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

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

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.

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