Policies & Legislation

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.

EC expected to dish out more pay-for-delay fines

Home/Policies & Legislation | Posted 01/08/2014

The European Commission (EC) is planning to fine French drugmaker Les Laboratoires Servier (Servier) and generics giant Teva Pharmaceutical Industries (Teva) in its latest round of investigations over so-called ‘pay-for-delay’ deals.

Companies required to update information on drugs

Home/Policies & Legislation | Posted 04/07/2014

The European Medicines Agency (EMA) announced that as of 16 June 2014 marketing authorization holders would be required to update the information on medicines authorized in the European Union.

EMA changes transparency plans to increase access to data

Home/Policies & Legislation | Posted 27/06/2014

The European Medicines Agency (EMA) has done an about-turn on its data transparency plans after the agency’s draft on the conditions of use for the EMA interface were criticized for limiting access to clinical trials data.

Massachusetts governor signs biosimilars substitution bill

Home/Policies & Legislation | Posted 27/06/2014

Massachusetts has become the latest US state to pass a law allowing substitution of a biosimilar for an originator biological, but with certain restrictions.

Court rules Canadian drug regulators cannot control generics' prices

Home/Policies & Legislation | Posted 27/06/2014

Canada’s Patented Medicine Prices Review Board (PMPRB) has been told that it has no jurisdiction over the pricing of generics.

EMA criticized for change in data transparency plans

Home/Policies & Legislation | Posted 20/06/2014

New Legislation approved by the European Parliament on 2 April 2014 aims to increase transparency with respect to clinical trials by making the results publicly available. The Clinical Trials Regulation, which is expected to take effect in 2016, will require the results of all new clinical trials to be published within a year of the trial ending. The way, however, that the European Medicines Agency (EMA) is proposing to make this data available has been criticized.

France to allow biosimilars substitution

Home/Policies & Legislation | Posted 21/02/2014

Pharmacists in France will now be allowed to substitute a biosimilar for the prescribed (reference) biological under certain conditions, including only when initiating a course of treatment and that the prescribing physician has not marked the prescription as ‘non-substitutable’.

WHO calls for better science-based regulations for biosimilars

Home/Policies & Legislation | Posted 13/06/2014

The sixty-seventh World Health Assembly (WHA) of the World Health Organization (WHO) closed on 24 May 2014, after adopting more than 20 resolutions on public health issues of global importance, one of which calls for better science-based regulations for biosimilars.

Europe–Japan cooperation on generics and biosimilars regulation

Home/Policies & Legislation | Posted 06/06/2014

Japanese and European generics groups have met to discuss increase regulatory cooperation between the two regions.

EMA and FDA report on collaborative efforts

Home/Policies & Legislation | Posted 16/05/2014

Key initiatives being undertaken between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) were discussed at a bilateral meeting which took place in London, UK, from 31 March to 1 April 2014.

Delaware passes biosimilars substitution law

Home/Policies & Legislation | Posted 25/04/2014

Delaware has become the latest US state to pass a law allowing substitution of a biosimilar for an originator biological, but with certain restrictions.

Australian price cuts make PBS affordable

Home/Policies & Legislation | Posted 11/04/2014

The price cuts for 121 medicines supplied through Australia’s Pharmaceutical Benefits Scheme (PBS) have made the PBS sustainable, according to Medicines Australia, a group that represents originator manufacturers.

Bill proposes extension of patents for new uses of biologicals

Home/Policies & Legislation | Posted 04/04/2014

A new bill, introduced in the US House of Representatives on 24 March 2014, proposes allowing patent owners to extend terms for certain biological patents if they are approved for new indications.

Indiana biosimilars substitution bill becomes law

Home/Policies & Legislation | Posted 28/03/2014

Indiana Governor Mike Pence signed into law on 25 March 2014 legislation that will allow pharmacists to substitute biosimilars that the US Federal Drug Administration (FDA) has approved as interchangeable with an originator biological under certain conditions.