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Policies & Legislation

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.

China to extend drug patents and tackle anticompetitive behaviour

According to reports, China is planning to increase patent protection on originator drugs to 25 years, increasing it by five years from the current patent protection period of 20 years. The country is also reportedly going to crack down on corruption and unfair competition in the pharmaceutical sector.

EC proposes waiver of SPCs to allow manufacturing of generics and biosimilars

The European Commission (EC) announced on 28 May 2018 a proposal to refine the intellectual property rules in Europe and thereby remove a major competitive disadvantage for European Union (EU) manufacturers.

Australia’s TGA publishes protocol to address drug shortages

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), announced in March 2018 the publication of a new protocol addressing drug shortages in Australia.