Biosimilars/General
Biosimilars and the safe harbor provision
In the US, the safe harbor provision exempts drug development and approval from patent infringement provisions, and courts have interpreted the safe harbor to apply broadly to Food and Drug Administration (FDA) regulated and approved products, including biologicals. However, courts have continued to struggle with the application of the safe harbor to different types of FDA submissions as the regulatory process has become more complex – and largely have continued to expand its scope.
Access to biosimilars in China, the EU and the US
Access to more affordable treatments is the main driver for the approval of biosimilars. But how does this accessibility vary between Europe, the US and China?
The Patients Association publishes new advice on switching to biosimilars
Patient advocacy group in the UK, The Patients Association, has published new information and an animated video about switching to biosimilars.
US oncologist says Medicare should not practice medicine
Clinical oncologist, Dr Debra Patt, who serves on the US Oncology Research Breast Cancer Committee and chairs the breast cancer subsection of the pathways task force for The US Oncology Network, expresses her opinion on a new policy introduced by Medicare, which she believes is ‘having a negative impact on a patient’s outcome’.
FDA and FTC collaborate to deter anti-competitive behaviour for biologicals
The US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced on 3 February 2020 that they would enhance their collaboration when it comes to anti-competitive behaviour in the biologicals’ marketplace.
Biosimilars applications under review by EMA – January 2020
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
Non-originator biologicals approved in Russia
Last update: 10 January 2020
In Russia, the regulatory body for the approval of medicines is Russia’s Ministry of Health (Министерство здравоохранения Российской Федерации; Rosminzdrav, Minzdrav).
FDA publishes historic drug approvals and searchable Purple Book
The US Food and Drug Administration (FDA) has released a dataset of drug approvals dating back to 1985 and an online, searchable version of the Purple Book of licensed biologicals.
Ontario becomes third Canadian province to switch patients to biosimilars
In Canada, the province of Ontario has followed Alberta and British Columbia in introducing a policy to switch certain patients to biosimilars.
Key issues for adalimumab biosimilars
Adalimumab is a popular and effective antibody treatment for inflammatory bowel disease (IBD). A recent position statement from the Belgian IBD research group (BIRD) reviews key issues surrounding the use of adalimumab biosimilars, including extrapolation, immunogenicity and switching [1].
