Biosimilars

EC approval of first ustekinumab biosimilar Uzpruvo

Biosimilars/News | Posted 16/01/2024

On 5 January 2024, the European Commission (EC) granted marketing authorization for the first ustekinumab biosimilar Uzpruvo (AVT04). The biosimilar of Uzpruvo is developed by Iceland-based biosimilar manufacturer Alvotech.

EMA recommends approval of ranibizumab biosimilar Rimmyrah

Biosimilars/News | Posted 12/12/2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use announced on 9 November 2023 that it had recommended granting of marketing authorization for Rimmyrah (ranibizumab), a biosimilar that references ophthalmology drug, Lucentis.

FDA approves Zymfentra and advances for Yuflyma in the US

Biosimilars/News | Posted 05/12/2023

On 23 October 2023, the US Food and Drug Administration (FDA) approved Celltrion’s Zymfentra (infliximab-dyyb) biosimilar as the first subcutaneous (SC) formulation of infliximab. In addition, Celltrion USA signed a contract with Ventegra to add Yuflyma (adalimumab-aaty) as a preferred formulary product in both public and private insurance markets.

Biological therapies for psoriasis: evaluating durability and persistent benefits

Biosimilars/Research | Posted 05/12/2023

A review by Rusiñol et al. emphasized the significant impact of biologicals on psoriasis management. Anti-IL-17 and anti-IL-23 biologicals are regarded as highly effective and long-lasting treatments in real-world scenarios, with IL-23-targeting biologicals showing the best safety profile and potential to modify the natural course of psoriasis.

Switches between biosimilars and their reference products

Biosimilars/Research | Posted 28/11/2023

Biologicals are the fastest-growing class of medications in the United States and account for a substantial and growing portion of healthcare costs. The Biologics Price Competition Act of 2009 created an abbreviated approval pathway for the US Food and Drug Administration (FDA) to help provide patients with greater access to safe and effective biological products. As of 1 November 2023, FDA has approved 44 biosimilar products, 7 of which are interchangeable biosimilars. These products can be used to treat many conditions such as chronic skin and bowel diseases, arthritis, kidney conditions, diabetes, multiple sclerosis, macular degeneration, and cancer.

EC approval of natalizumab, aflibercept and tocilizumab biosimilars

Biosimilars/News | Posted 28/11/2023

In September 2023, the European Commission (EC) granted marketing authorization for the biosimilars of Tyruko (natalizumab), Yesafili (aflibercept), and Tyenne (tocilizumab).

Latin America's biosimilars market: regulatory, institutional, and technological aspects

Biosimilars/Research | Posted 21/11/2023

According to a study led by Bas (2023), the Latin American (LA) biosimilars market is positioned for substantial growth over the next decades as a cost-effective alternative to expensive patented biomolecules [1].

EMA recommends approval of first ustekinumab biosimilar Uzpruvo

Biosimilars/News | Posted 14/11/2023

On 9 November 2023, the European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Uzpruvo (ustekinumab), a biosimilar of reference product Stelara, intended for the treatment plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease in adults.

FDA approves first interchangeable ustekinumab biosimilar Wezlana

Biosimilars/News | Posted 07/11/2023

On 31 October 2023, the US Food and Drug Administration (FDA) approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.

Canada’s Prince Edward Island adopts biosimilars switching policy

Biosimilars/General | Posted 07/11/2023

Canada’s Prince Edward Island (PEI) becomes the 11th Canadian jurisdiction to announce the adoption of biosimilars switching policies.