Policies & Legislation
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.
US government advances five bills to increase generics competition
The US House Energy & Commerce Committee’s Health Subcommittee has advanced five bills related to generic drug competition. The bills have not yet been passed but will each be considered by the full committee.
Anti-price gouging: legislation introduced in Senate while Maryland’s appeal is rejected
Under current law in the US, pharmaceutical companies can raise prices of their products without justification. A 2017 Public Citizen survey revealed that only 14% of the world’s top 29 pharmaceutical companies were willing to limit annual price increases to less than 10%. In February 2019, US senators proposed legislation to reduce prescription drug price gouging, while Maryland’s appeal of a ruling that struck down its anti-price gouging regulation was rejected.
New safety requirements for EU medicines
As of 9 February 2019, most prescription medicines and some over-the-counter medicines supplied in the European Union (EU) are legally obligated to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging.
Two more countries added to EU-US mutual recognition agreement
The European Medicines Agency (EMA) announced on 11 February 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, Poland and Slovenia.
