Biosimilars/General
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].
Adalimumab biosimilars in Europe: a review
A recent position statement from the Belgian inflammatory bowel disease (IBD) research group (BIRD) reviews the five biosimilars of adalimumab available in the European Union (EU) [1]. Adalimumab, which has been marketed under the brand name Humira, is a popular antibody treatment for a number of inflammatory conditions.
Swiss position statement on the use of biosimilars in IBD
Experts from the Swiss Society of Gastroenterology have provided a position statement on the use of biosimilars in inflammatory bowel disease (IBD). The position paper summarizes key regulatory and clinical issues around biosimilars to help improve clinician and patient awareness.
Eli Lilly and Novo Nordisk launches lower-priced insulin options
Originator insulin makers Eli Lilly and Novo Nordisk have both announced the introduction of additional reduced cost insulin options for patients.
WHO prequalifies first biosimilar
The World Health Organization (WHO) has prequalified its first biosimilar – trastuzumab – in a move that the organization says, ‘could make this expensive, life-saving treatment more affordable and available to women globally’.
Canadian gastroenterologists issue biosimilar position statement
The Canadian Association of Gastroenterology (CAG) and Crohn’s and Colitis Canada announced on 24 October 2019 that they had issued a joint position statement on the use of biosimilars for the treatment of inflammatory bowel disease (IBD) [1].
