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 [1].

The patents on Kadcyla expired in Europe on 23 June 2020 and will expire in the US on 8 September 2026 [2].

Editor’s comment
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.

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Call for compulsory license for biosimilar trastuzumab emtansine

 
References
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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