Policies & Legislation
EU-US mutual recognition extended to include Portugal
The European Medicines Agency (EMA) announced on 20 September 2018 that the Mutual Recognition Agreement between the European Union and the US had been extended to include one additional EU Member State, Portugal.
Australia encouraging biosimilars and mandating drug shortage reporting
In an effort to address both the rising prices of medicines and the risk of drug shortages in Australia the country has introduced drivers to encourage the use of biosimilars and mandatory reporting of drug shortages.
EMA aims to improve the availability of medicines in Europe
A European Union (EU) task force, which was set up by European regulators, has published its work programme for 2019/20 and announces a multi-stakeholder workshop.
Biosimilars no longer eligible for parallel processing in Australia
Biosimilars will no longer be able to request parallel processing when submitting a biosimilar application for approval in Australia.
Mexico trade deal impacts biologicals exclusivity
The US announced a new ‘understanding’ on trade with Mexico on 27 August 2018. The announcement comes as part of efforts to re-negotiate the North American Free Trade Agreement (NAFTA) between the US, Canada and Mexico, which first came into force in January 1994.
AbbVie ruled to pay nearly US$450 million for antitrust violations
AbbVie and their partner firm Besins Healthcare have been ordered by the Federal Trade Commission (FTC) to pay US$448 million for preventing generics competition to their testosterone product Androgel. This is the largest amount ever seen in an FTC antitrust case.
EU reinforces collaborations with US and Japan
The European Union (EU) is reinforcing its collaborations with both the US and Japan.
Russian court approves first compulsory licence
A court in Moscow has made history by granting a compulsory licence to Russian drugmaker Ukrenergo to make a generic version of Celgene Corporation’s (Celgene) flagship blood cancer drug Revlimid (lenalidomide).
CFDA to come under national market supervision administration
A sweeping government restructuring plan was approved by China’s National People’s Congress on 17 March 2018. The reorganization will see China’s drug regulator, the China Food and Drug Administration (CFDA), merged into an overarching market supervision administration.
Hatch aims to promote biosimilars and generics and restrict litigation
Senator Orrin Hatch filed an amendment to the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which was advanced to the Senate by the Judiciary Committee on 14 June 2018.
