Trastuzumab emtansine manufacturers

About trastuzumab emtansine

Trastuzumab emtansine manufacturers are led by the originator, Roche (Genentech), which sells it as Kadcyla, with biosimilar versions developed in India and other markets. Trastuzumab emtansine (T-DM1) is an antibody-drug conjugate that links the HER2 antibody trastuzumab to the cell-killing drug DM1. It delivers chemotherapy directly to HER2-positive breast cancer cells. Pharmaceutical companies can source T-DM1 through biosimilar licensing, supply or technology transfer where patents allow.

Trastuzumab emtansine key facts

Trastuzumab emtansine manufacturers and licensing history

Genentech, part of Roche, developed T-DM1 using ImmunoGen's linker and maytansinoid payload technology. The FDA approved Kadcyla in February 2013 for metastatic HER2-positive breast cancer, as one of the first antibody-drug conjugates for solid tumours. The EU followed in 2013.

In May 2019, the FDA approved T-DM1 for early breast cancer with residual disease after neoadjuvant treatment, based on the KATHERINE trial. In metastatic disease, the newer trastuzumab deruxtecan (Enhertu) has replaced it in some settings.

Biosimilar T-DM1 has been launched in India, and other developers are working on versions for emerging markets. Antibody-drug conjugates are complex to copy: buyers should confirm antibody comparability, drug-to-antibody ratio, conjugation process, GMP status and patent position before choosing a partner.

Trastuzumab emtansine dosage forms and dossier types

T-DM1 is supplied as a lyophilised powder in 100 mg and 160 mg single-dose vials.

Trastuzumab emtansine regulatory and patent status

The FDA approved T-DM1 in February 2013 and for adjuvant use in May 2019. It is approved in the EU and many other markets. No biosimilar is approved in the US or EU, but biosimilars have been launched in India. Check patents on the antibody, linker, payload and process in each target market before development.

Trastuzumab emtansine mechanism of action and therapeutic use

The trastuzumab part of T-DM1 binds HER2 on cancer cells, and the conjugate is taken inside the cell. There, DM1 is released and disrupts microtubules, killing the cell. This targets chemotherapy to HER2-positive cancer cells and spares most normal cells. T-DM1 is given every 3 weeks for HER2-positive early and metastatic breast cancer.

Trastuzumab emtansine licensing and sourcing

T-DM1 suppliers and licensing partners typically offer biosimilar out-licensing, finished-product supply or technology transfer for emerging markets. Buyers usually compare comparability data, conjugation capability, GMP status and patent position. Current offers and supplier contacts are listed among the trastuzumab emtansine manufacturers on Pipelinepharma.

Frequently asked questions about trastuzumab emtansine

Who manufactures trastuzumab emtansine? Roche (Genentech) is the originator and sells Kadcyla. Biosimilar versions have been launched in India.

Is there a biosimilar of trastuzumab emtansine? Biosimilars have been launched in India, but none is approved in the US or EU.

What is trastuzumab emtansine used for? T-DM1 is used for HER2-positive early breast cancer with residual disease after neoadjuvant treatment, and for HER2-positive metastatic breast cancer.

What forms and strengths of trastuzumab emtansine are available? T-DM1 is available as a lyophilised powder in 100 mg and 160 mg vials for intravenous infusion.

What is the difference between T-DM1 and trastuzumab deruxtecan? Both are HER2-directed antibody-drug conjugates. T-DM1 uses the payload DM1, while trastuzumab deruxtecan uses a topoisomerase inhibitor and has replaced T-DM1 in some settings.