Keytruda (generic name is pembrolizumab), manufactured and marketed by Merck & Co, is the most successful medicine, recording worldwide sales of $29.5 billion in 2024. It is used to treat multiple forms of cancer.
Under the terms of the agreement, both companies will be jointly responsible for developing and manufacturing the biosimilar candidate and sharing costs and responsibilities, Hyderabad-based DRL said in a statement on Thursday.
Subject to certain exceptions, each party will have the right to commercialise the product globally.
Unlike traditional generics, which often face automatic patent infringement claims, biosimilars are developed more like original drugs, complete with clinical trials and patent disclosures, giving them a better chance of overcoming legal challenges. Also, Merck’s core patents on pembrolizumab in the US are expected to start expiring around 2028.
“This (collaboration) demonstrates our ability to develop and manufacture high quality and affordable treatment options for patients worldwide,” Erez Israeli, chief executive of DRL, said.Róbert Wessman, chairman and CEO of Alvotech, said, “The agreement enables us to increase the availability of cost-effective, critical biologic medications to patients worldwide.”Keytruda is approved in the US to treat 40 cancers, unlike most medicines that treat a few indications or medical conditions.
In India, it is approved for use in 17 indications across 10 cancers or tumour types. Oncologists mostly prescribe it to treat certain types of lung cancers, followed by gastrointestinal cancer, triple-negative breast cancer and head and neck cancers.
Keytruda helps the body’s immune system, which is the T-cells, to detect and fight cancer cells that hide and spread in organs.
“Oncology has been a top focus therapy area for us, and this collaboration will enhance our capabilities in oncology, as pembrolizumab currently represents one of the most critical therapies in immuno-oncology,” Israeli said.
Keytruda has been out of reach for most patients in India due to its exorbitant cost – roughly about Rs 2 lakhs for each dose. However, with Merck’s patent set to expire in a few years and with Indian drug manufacturers looking to come up with more affordable versions of the drug it may play a crucial role in widening adoption across a larger cohort of patients.
