Biosimilars/General
Biosimilars approved in Canada
Last update: 6 August 2024
In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB) of Health Canada.
Humira's resilience in the face of biosimilar competition
AbbVie’s Humira (adalimumab) has retained more than 80% of patients in the last year (Q3/2023 to Q2/2024), despite the availability of nine lower-priced rival products available in the US. This raises questions among drug pricing experts and analysts about whether the market for prescription biosimilars can survive in its current form.
Biosimilars approved in the US
Last update: 23 July 2024
In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Biosimilars approved in Europe
Last update: 16 July 2024
In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.
Boehringer Ingelheim to expand access to adalimumab biosimilar
On 13 May 2024, Boehringer Ingelheim (Boehringer) announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer’s biosimilar to AbbVie’s Humira (adalimumab) in the US.
Challenges and progress in the registration of biosimilars in Latin America
Biosimilar medicines offer an effective and economical alternative to biotechnological medicines, with a rapidly expanding global market. However, Latin America still faces several significant challenges. The obstacles and advancements experienced in recent years are detailed below.
Canada's path to biosimilar adoption and healthcare accessibility: insights from British Columbia
Canada’s British Columbia transitioned to biosimilars in November 2019, achieving significant cost savings reinvested in BC PharmaCare. This initiative has improved drug coverage, expanding access to various medications and medical devices.
Disruption in the US adalimumab market
In April 2024, Evernorth Health Services in the US announced that a biosimilar of AbbVie’s Humira ( adalimumab) will be available for US$0 out of pocket for eligible patients of its specialty pharmacy, Accredo. This announcement follows the news that prescriptions for adalimumab biosimilars have spiked to 36% after leading pharmacy benefit manager CVS Caremark removed the branded reference product from its major national commercial formularies in January 2024.
Addressing the persistent gap in Medicare access to Humira biosimilars
In an article by Dr Joshua Cohen, he discusses the challenges facing the adoption of biosimilars in the US, particularly focusing on Medicare beneficiaries' access to these lower-cost alternatives to brand-name biologicals like Humira.
Brazil advances in follow-on biologicals/biosimilars approvals, trailing Europe
Brazil is the fourth-largest market in terms of approved follow-on biological medications worldwide. As of May 2023, Brazil has approved 52 follow-on biological medicines [1] and approximately 30 biological products awaiting testing or already being tested by the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária) [2].
