Biosimilars/General
Chinese biosimilars go global: growth, partnerships, and challenges
Chinese biosimilars have gained global traction, with companies like Henlius and Bio-Thera securing international approvals. Despite challenges, China’s innovation and partnerships position it as a key biopharmaceutical player.
Biosimilars approved in Europe
Last update: 22 April 2025
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.
Biosimilars approved in Canada
Last update: 28 March 2025
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.
Stelara biosimilars enter US market with 85% discount in 2025
In February 2025, Teva Pharmaceuticals and Alvotech announced the availability of Selardsi (ustekinumab-aekn) in the US, followed by Sandoz’s Pyzchiva (ustekinumab-ttwe). These two products are biosimilars to the originator drug, Johnson & Johnson’s Stelara (ustekinumab).
IFPMA publishes position on pharmacy-mediated substitution for biosimilars
In January 2025, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published a position paper, ‘Pharmacy-mediated substitution for biosimilars’.
The ustekinumab shift: biosimilars displace Stelara’s market leadership
The ustekinumab market is heating up as biosimilar developers aggressively challenge the dominance of Stelara, Johnson & Johnson’s blockbuster drug for autoimmune diseases. With eight biosimilars approved in Europe and seven in the US, the competition is fierce, and the stakes are high.
Brazilian law establishes December 16 as National Biosimilar Day
On 6 January 2025, President Luiz Inácio Lula da Silva sanctioned Law 15.087/25, officially declaring December 16 as National Biosimilar Drug Day in Brazil. The law, published in the Official Gazette of the Union, aims to raise awareness about the importance of biosimilars in the healthcare system.
Biosimilars approved in the US
Last update: 25 February 2025
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).
Biologicals and biosimilars available for IBD in Canada
The GI Society (Canadian Society of Intestinal Research) recently published an updated list of originator biologicals and biosimilars used to treat inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), in Canada.
Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia
In recent years, biosimilar medicines have gained increased support and access in Australia through the Pharmaceutical Benefits Scheme (PBS), a government programme designed to subsidize essential medicines and make them affordable for all Australians. Biosimilars are versions of original biological medicines that are highly similar in terms of quality, safety, and efficacy but are generally more affordable.
