News & Events.

30 Sep.

On 19 September 2022, Sandoz announced positive results following its ROSALIA I/III clinical trial study for its proposed biosimilar denosumab. This follows the August announcement that Lannett Company successfully completed subject dosing in the clinical trial of its biosimilar insulin glargine.

30 Sep.

At the online session of BIOS 22, Biosimilar medicines: changing patient care pathways, changing outcomes, speaker Nadia Amer, Health Economist Analyst at the Health Product Department in the Caisse Nationale d’Assurance Maladie (CNAM) in France, delivered a presentation based on concrete examples and experiences of biosimilar medicines in France [1].

30 Sep.

In court proceedings that concluded in August 2022, the Canadian Federal Court dismissed applications for judicial review put forward by AbbVie regarding the approval and marketing authorization of JAMP Pharma's Simlandi (adalimumab) product [1]. This confirms that Notice of Compliance (NOC) regulations do not apply to biosimilars when reference products are not marketed in Canada.

23 Sep.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued on 19 September 2022 a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar. This will allow more patients to have access to biological medicines necessary for treating diseases such as cancer, diabetes and rheumatic diseases.

23 Sep.

After reviewing the regulatory landscape for biosimilars [1] and access to biosimilars for cancer treatments in Latin America [2], authors Teran et al. advised several recommendations to address challenges related to poor access to biosimilars in Latin America healthcare systems.

23 Sep.

On 18 August 2022, South Korea-based biologicals specialist Celltrion announced that its bevacizumab biosimilar, Vegzelma (CT-P16), had received European Commission (EC) approval.

23 Sep.

Abstract
An online roundtable discussion entitled ‘Front-loading biosimilar development with analytical characterization’ was hosted by BioPharmaSpec. The panellists discussed different regulatory approaches to the clinical trials needed for approval and how this can affect structural and functional characterization; the best way to ‘front-load’ characterization in comparability studies; orthogonality and its role in reducing biosimilar development costs; and how to develop an integrated strategy for structural and functional data assessments.

16 Sep.

On 29 August 2022, the ranibizumab biosimilar Ranivisio (FYB201), developed by Bioeq – a joint venture between Formycon and Polpharma Biologics, was granted marketing approval by the European Commission (EC).

16 Sep.

Sandoz, the generics division of Novartis, announced on 21 July 2022 that the US Food and Drug Administration (FDA) had accepted the supplemental biologics license application for the high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017) (adalimumab-adaz).

16 Sep.

Big pharma company Novartis announced on 25 August 2022 that it will spin off its generics and biosimilars arm, Sandoz.

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