Policies & Legislation
EU public consultation on revised framework for compulsory licensing of patents
The European Commission had opened a public consultation on ‘Intellectual property (IP) – revised framework for compulsory licensing of patents’. This was opened from 7 July 2022 to 29 September 2022.
Canada upholds decision to approve biosimilars where reference product is not marketed
In court proceedings that concluded in August 2022, the Canadian Federal Court dismissed applications for judicial review put forward by AbbVie regarding the approval and marketing authorization of JAMP Pharma's Simlandi (adalimumab) product [1]. This confirms that Notice of Compliance (NOC) regulations do not apply to biosimilars when reference products are not marketed in Canada.
PDUFA VI: FDA could promote generics competition
In the US, the current Prescription Drug User Fee Act (PDUFA) is due to expire in September 2022. A recent report calls for the new iteration of the act (VI) to increase Food and Drug Administration’s (FDA) authority to promote generic competition [1].
House bill passes FDA funding fees but conflicts with Senate bill
In the Unites States (US), the House of Representatives voted to pass legislation to reauthorize the fees that help fund the US Food and Drug Administration (FDA). However, there are some conflicts between the House and parallel Senate bill that need to be overcome before either can be passed.
US Senate clarifies status of interchangeable biosimilar exclusivity
The United States (US) Senate Health, Education, Labor and Pensions (HELP) Committee released a draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA) on 17 May 2022.
Nomenclature of biologicals and biosimilars in Peru
This article, the last in a series on the nomenclature of biological and biosimilar medicines in various Latin American countries based on the study by Iglesias Galiano M in 2021, analyses the management and implementation of the nomenclature of biological and biosimilar medicines in Peru [1].
United States legislation to improve access to insulin
In the US, a bill was passed in late March 2022 to cap the monthly cost of insulin at US$35 for insured patients. In addition, in early April 2022, a bipartisan bill to reform the US Food and Drug Administration (FDA) review and approval process for complex generics/biosimilars was passed.
Nomenclature of biologicals and biosimilars in Chile
Continuing with the series of articles on the management and implementation of the nomenclature of biological and biosimilar medicines in Brazil, Argentina, Mexico and Colombia, based on the publication of an extensive study carried out in Peru by Iglesias Galiano M in 2021, this article will provide a summary focused on Chile [1].
Nomenclature of biologicals and biosimilars in Colombia
This article analyses the realities of Colombia as part as a broader study carried out by Iglesias Galiano M, focused on some reference countries as well as those countries of the region with level IV according to Pan American Health Organization (PAHO) classification, which have implemented guidelines for the authorization of biotechnological and biosimilar medicines in relation to the management of the nomenclature.
FDA funds regulatory science pilot for biosimilars
The US Food and Drug Administration (FDA) has announced US$5 million funding for research proposals under the Biosimilar User Fee Act (BsUFA III) Regulatory Science Pilot Program.
