See the DrugPatentWatch profile for canakinumab

Canakinumab is a human monoclonal antibody that targets interleukin-1 beta (IL-1β), a cytokine that plays a crucial role in mediating inflammatory responses. It is currently marketed under the brand name Ilaris by Novartis for the treatment of several autoinflammatory diseases. However, the patent for canakinumab has expired, paving the way for biosimilar development.

Biosimilars are biologic medical products that are highly similar to an already licensed reference biologic product. They are designed to have similar safety, purity, and potency as the reference product, and are typically introduced to the market at lower prices.

Key players in the development of biosimilar canakinumab include:

1. Samsung Bioepis: Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, has announced the initiation of a phase 3 clinical trial for its biosimilar candidate, SB15, which targets canakinumab. The trial aims to establish the pharmacokinetic (PK) and pharmacodynamic (PD) similarity, as well as the safety and efficacy of SB15, in comparison to Ilaris.

2. Coherus Biosciences: Coherus Biosciences, a leading biosimilar company based in the United States, has a canakinumab biosimilar candidate in its pipeline. The company has not yet disclosed detailed information about its development progress.

3. Cinfa Biotech: Spanish biosimilar developer Cinfa Biotech has a canakinumab biosimilar candidate, CB201, in its pipeline. The company has announced positive results from a phase 1 clinical trial, demonstrating the similarity of CB201 to Ilaris in terms of PK, PD, safety, and immunogenicity.

4. STADA Arzneimittel: German generics and biosimilars company STADA Arzneimittel has a canakinumab biosimilar candidate in its development pipeline. The company has not yet disclosed detailed information about its progress.

These key players are actively working on the development of biosimilar canakinumab, aiming to provide more affordable treatment options for patients with autoinflammatory diseases.

Sources:

1. Samsung Bioepis. (2021). Samsung Bioepis Announces Initiation of Phase 3 Clinical Trial for SB15, a Proposed Biosimilar to Ilaris® (Canakinumab). <https://www.samsungbioepis.com/en/news/press-release/samsung-bioepis-announces-initiation-of-phase-3-clinical-trial-for-sb15-a-proposed-biosimilar-to-ilaris-canakinumab>
2. Coherus Biosciences. (2021). Pipeline. <https://coherus.com/pipeline/>
3. Cinfa Biotech. (2021). Cinfa Biotech Announces Positive Phase I Results for its Biosimilar Candidate CB201, a Monoclonal Antibody Targeting IL-1β. <https://www.cinfa.com/cinfa-biotech-announces-positive-phase-i-results-for-its-biosimilar-candidate-cb201-a-monoclonal-antibody-targeting-il-1%ce%b2/>
4. STADA Arzneimittel. (2021). Biosimilars. <https://www.stada.com/en/group/research-development/biosimilars/>
5. DrugPatentWatch. (2021). Canakinumab (Ilaris). <https://www.drugpatentwatch.com/ilaris-canakinumab-patent-expiration-date/>