Policies & Legislation
Five key questions about the ‘patent dance’ answered
Law firm Fish and Richardson have provided answers to five key questions for biosimilar makers when it comes to the patent dance.
CMS launches insulin co-pay at US$35
The Centers for Medicare & Medicaid Services (CMS) in the US has launched a new model to reduce co-pays for insulin products to US$35.
Alberta delays deadline for forced medication switch by six months
The Canadian province of Alberta has delayed its introduction of a switching policy to biosimilars for patients using biologicals for six months.
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.
