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Policies & Legislation

Opposition party in Alberta, Canada fights biosimilar switching policy

The opposition New Democratic Party (NDP) in Alberta, Canada has urged the province not to force patients to switch to biosimilars, citing concerns about patient safety.

Hospira asks Federal Circuit to reconsider Safe Harbor ruling

In December 2019, Federal Circuit judges upheld a Delaware district court’s judgment of patent infringement and its order that Hospira pay US$70 million in damages to Amgen [1]. Then in January 2020 Hospira filed a petition for rehearing ‘en banc’ asking the full Federal Circuit to reconsider the Safe Harbor ruling and reverse the judgment of infringement.

Allergan, Ironwood settle Linzess patent dispute

In early 2020, Allergan and Ironwood Pharmaceuticals (Ironwood) reached agreements with Mylan Pharmaceuticals (Mylan), Sandoz and Teva Pharmaceutical Industries (Teva) to protect their irritable bowel syndrome (IBS) treatment Linzess (linaclotide).

China’s procurement programme cuts drug prices by half

China’s national generics procurement programme, the second phase of which ended in January 2020, included 33 different drugs and cut prices by 53% on average.

US patent office rules in Biogen’s favour on Tecfidera

Biogen has won a patent challenge from Mylan over multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate).

US-Mexico-Canada agreement to benefit generics makers

The amended United States-Mexico-Canada Agreement (USMCA) will benefit biosimilar and generic drug companies through changes to patent protection for originator drugs.

European Court of Justice backs UK in pay-for-delay fine against GSK

The European Court of Justice has backed an earlier decision by the UK financial regulator, the Competition and Markets Authority (CMA), to fine pharma giant GlaxoSmithKline (GSK) in connection with ‘pay for delay’ deals for one of its off-patent medications.

New pricing system for drugs in Russia

The Russian Government has passed a decree mandating ceiling prices for drugs on the country’s essential drugs list.

Chemically synthesized polypeptides to use biosimilars pathway

The US Food and Drug Administration (FDA) is supporting a change in the government spending bill that will allow for chemically synthesized polypeptides to also be classified as biologicals.

US government department proposes rule to lower drug prices for its citizens

The US Department of Health and Human Services (HHS) announced a string of changes in November 2019, including a proposal to lower drug prices for US citizens based on Trump’s ‘most favored nation’ approach.