India-based generics manufacturer Zydus Cadila (Zydus) announced on 24 May 2021 the launch of its trastuzumab emtansine ‘similar biologic’ Ujvira in India. The launch, according to Zydus ‘marks the world’s first biosimilar antibody drug conjugate (ADC) of trastuzumab emtansine’.
Trastuzumab emtansine ‘similar biologic’ Ujvira launched in India
Biosimilars/News | Posted 11/06/2021 0 Post your comment
Trastuzumab emtansine is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab (Herceptin) covalently linked to the cytotoxic agent emtansine (DM1). It is a highly effective drug for treating both early and advanced human epidermal growth factor receptor 2 positive (HER2+) breast cancer. HER2+breast cancer is considered an aggressive form and constitutes 20% to 25% of all breast cancers.
The ‘similar biologic’ is considered a developmental breakthrough due to its complexity in manufacturing and similarity assays.
Dr Sharvil Patel, Managing Director, Cadila Healthcare Limited said that ‘the launch of Ujvira reinforces the innovation capabilities that India has to be able to create complex therapies like ADCs’. He added that ‘this research breakthrough enables access to a critical drug for patients who are undergoing therapy for breast cancer’.
Zydus is making the drug available at Rs.32495 for a 100 mg vial, an almost 80% reduction compared to the cost of the originator drug, Roche’s Kadcyla (trastuzumab emtansine).
Similar biologics have been on the market in India for some years already and India has by far shown the greatest acceptance of such products. However, regulatory guidelines for similar biologics were only implemented in September 2012. Prior to this ‘similar biologics’ were approved in India following the generics pathway, but with more data being required .
The patents on Kadcyla expired in Europe on 23 June 2020 and will expire in the US on 8 September 2026 .
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘similar biologics’ approved in India might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
LATIN AMERICAN FORUM – Coming soon!
To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.
LATIN AMERICAN FORUM – Próximamente!
Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.
1. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 11]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
2. Derbyshire M. Patent expiry dates for best-selling biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
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Source: Zydus Cadila