Policies & Legislation
US FDA acts to improve transparency and predictability for new generics applications
On 18 June 2019, the US Food and Drug Administration (FDA) released a ‘Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high quality, lower cost generic drugs’. Here, the agency outlines that, to facilitate American patients’ access to lower-cost generic medicines, they are taking steps to enhance and streamline the development and approval process of high quality generic drugs.
Canada’s British Columbia to switch patients to biosimilars
British Columbia has become the first Canadian province to stop coverage of originator biologicals and switch patients to biosimilars for certain indications.
Bulgaria and Cyprus added to EU-US mutual recognition agreement
The European Medicines Agency (EMA) announced on 29 April 2019 that the mutual recognition agreement (MRA) between the European Union (EU) and the US had been extended to include two additional EU Member States, Bulgaria and Cyprus.
US considering eight years protection for biologicals in China
Makers of copy biologicals in China may be set to get a further boost, as the Trump administration is said to be considering conceding to China’s proposal to shorten the period of protection granted to US drugmakers’ biologicals in the country.
FDA’s Orange and Purple Books to be improved and updated
On 8 May 2019, the US House of Representatives unanimously passed two bills that aim to enhance the utility of the US Food and Drug Administration’s (FDA) Orange Book for generics makers and the Purple Book for biosimilars makers.
New biosimilar guide for pharmacists in Australia
During the Generic and Biosimilar Medicines Association’s (GBMA) Biosimilar Week, Federal Minister for Health, Greg Hunt, introduced Biosimilar Week 2019 along with the launch of the Biosimilar Hub, which included a set of specific guidelines geared towards pharmacists.
Automatic pharmacist substitution of biosimilars in Germany
Pharmacists in Germany may soon be able to carry out automatic substitution of biosimilars in the country.
Australia’s TGA considering whether to publish drugs under evaluation
Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) is consulting on whether it should publish that a prescription medicine is under evaluation.
Health Canada announces naming convention for biologicals
Following a number of stakeholder consultations including the 2018 Consultation on the Naming of Biologic Drugs [1], Health Canada has decided that biological drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix. Under this naming convention, both the brand name and non-proprietary name should be used throughout the medication use process so that biologicals that share the same non-proprietary name can be distinguished by their unique brand names.
Online consultation on biological drug naming in Canada
Health Canada and the Institute for Safe Medication Practices Canada conducted an online consultation on the naming of biological drugs in 2018.
