Biosimilars/General
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 program designed to subsidizes 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.
SBR issues consensus on interchangeability of reference products and biosimilars
On 25 September 2024, the Brazilian Society of Rheumatology (SBR, Sociedade Brasileira de Reumatologia) shared its position and consensus on the interchangeability between reference products and biosimilars, a topic of great importance for clinical practice, especially in light of recent regulatory developments by Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária) and other international authorities.
Innovative direct purchase agreement sees adalimumab biosimilar prices slashed
On 1 October 2024, Blue Shield of California in the US announced that it will pay far less for an adalimumab biosimilar. The transparent net price paid by the health plan provider will be US$525 per monthly dose, compared to the market-reported net price of reference product Humira at US$2,100.
Stelara biosimilar available at US$0 for Accredo patients
On 5 September 2024, Evernorth Health Services in the US announced that a biosimilar of Johnson and Johnson’s Stelara (ustekinumab) will be available for US$0 out of pocket for eligible patients of its specialty pharmacy, Accredo.
Ten best-selling biosimilars in Brazil in 2023
Biosimilars experienced a notable increase in sales during 2023, according to a study published by the Brazilian Association of Generic and Biosimilar Drug Industries (PróGenéricos). The data reveal that about 892,000 units of biosimilars were sold, representing a 43% growth compared to 2022.
International biosimilars players expanding their presence in China
The market for copy biologicals in China has significantly grown over the past decade. By early 2022, over 60 pharmaceutical companies were involved in the development of copy biological products [1].
Boehringer and GoodRx make Humira biosimilar available at 92% discount
On 18 July 2024, it was announced that Boehringer Ingelheim (Boehringer) and GoodRx, the leading prescription savings platform in the US, launched a patient affordability initiative. From now on, Boehringer's citrate-free adalimumab-adbm, a biosimilar to Humira (adalimumab), will be available at a 92% discount to the list price of the AbbVie originator drug, exclusively on GoodRx.
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).
