Policies & Legislation

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.