Biosimilars/General

Biosimilars approved in Europe

Biosimilars/General | Posted 08/07/2011

Last update: 20 June 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 the US

Biosimilars/General | Posted 14/08/2015

Last update: 22 May 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).

Biosimilars approved in Australia

Biosimilars/General | Posted 21/02/2014

Last update: 6 May 2025

In Australia, the legal framework for approving medicines was established via the Therapeutic Goods Act 1989.

Chinese biosimilars go global: growth, partnerships, and challenges

Biosimilars/General | Posted 30/04/2025

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 Canada

Biosimilars/General | Posted 31/01/2014

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

Biosimilars/General | Posted 28/03/2025

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

Biosimilars/General | Posted 21/03/2025

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

Biosimilars/General | Posted 12/03/2025

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

Biosimilars/General | Posted 05/03/2025

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.

Biologicals and biosimilars available for IBD in Canada

Biosimilars/General | Posted 26/11/2024

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

Biosimilars/General | Posted 20/11/2024

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.

SBR issues consensus on interchangeability of reference products and biosimilars

Biosimilars/General | Posted 13/11/2024

On 25 September 2024, the Brazilian Society of Rheumatology (Sociedade Brasileira de Reumatologia, SBR) 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, ANVISA) and other international authorities. 

Innovative direct purchase agreement sees adalimumab biosimilar prices slashed

Biosimilars/General | Posted 15/10/2024

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

Biosimilars/General | Posted 08/10/2024

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/General | Posted 01/10/2024

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

Biosimilars/General | Posted 18/09/2024

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

Biosimilars/General | Posted 10/09/2024

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.

Humira's resilience in the face of biosimilar competition

Biosimilars/General | Posted 30/07/2024

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.

Boehringer Ingelheim to expand access to adalimumab biosimilar

Biosimilars/General | Posted 03/07/2024

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

Biosimilars/General | Posted 25/06/2024

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.