Policies & Legislation
Bills increase access to affordable drugs in the US and the Philippines
In the opening months of 2021, a bill was proposed to make more biosimilars accessible to a greater proportion of the US state of Minnesota’s residents. In addition, a bill was passed in Wisconsin that will give pharmacists the ability to recommend cheaper drug options. And, in the Philippines, a bill has been filed to encourage the use of biosimilar drug products.
EU Court of Justice upholds Lundbeck fines over pay-for-delay
On 25 April 2021, Danish drug company Lundbeck and four generic drugmakers lost their appeal against European Union antitrust fines of Euros 146 million (US$172 million), imposed in 2013.
Colorado to import drugs from Canada and beyond
In 2019, a law was passed in the US state of Colorado to allow the import of prescription drugs from Canada. A bill to expand drug imports, and include those from additional nations, cleared at House committee on 7 April 2021. This hopes to see imports from additional countries like Australia, France and Japan.
Federal Court maintains decision on infliximab patent validity
On 21 January 2021 and following appeal, the US Federal Court again found that the patent held by The Kennedy Trust for Rheumatology Research regarding the use of infliximab (Janssen’s Renicade) is valid and infringed by Hospira’s biosimilar, Inflectra.
Teva not liable in US due to FDCA implied preemption
In early 2021, implied preemption related to the Federal Food, Drug and Cosmetic Act of 1938 (FDCA or the Act) has prevented generics manufacturer Teva Pharmaceuticals (Teva) from being held liable for three different failure-to-warn theories.
China improves generics injection consistency evaluation
China’s National Medical Products Administration (NMPA) announced regulatory improvements to the generic injections’ quality and efficacy consistency evaluation in May 2020.
Italy simplifies over-the-counter generics price and reimbursement
The Italian Drugs and Medicines Agency (Agenzia Italiana del Farmaco, AIFA) has simplified its price and reimbursement procedure for class C generic/biosimilar medicines. As of February 2021, generic/biosimilar versions of over-the-counter class C reference products will automatically be classified as class C products.
Australia launches new medicines road map and substitution policy
The Australian Government has launched a Medicine-Medical Product Manufacturing Road Map and new legislation to support medicine substitutions.
Problems with the tiered pricing policy for generics in Korea
In order to try to improve the quality of generics and ensure an efficient and competitive generics market, the Korean Ministry of Food and Drug Safety (MFDS) introduced a ‘tiered system’ to restructure the drug pricing for generics in July 2020. However, since its introduction the system has not gone without criticism.
EMA and EU medicines regulatory joint five-year strategy
The Europeans Medicines Agency (EMA) and the European Union’s (EU) Heads of Medicines Agencies (HMA) have published their joint strategy to 2025: Protecting public health in a time of rapid change [1].
