Alvotech, a biopharmaceutical company, and Dr. Reddy’s Laboratories, a pharmaceutical company, have announced a partnership to develop a biosimilar for the cancer drug pembrolizumab. Pembrolizumab is a monoclonal antibody used to treat various types of cancer, including melanoma, lung cancer, and head and neck cancer. The drug is marketed under the brand name Keytruda by Merck & Co. and has been a significant revenue generator for the company.
The partnership between Alvotech and Dr. Reddy’s aims to develop a biosimilar version of pembrolizumab, which would be a more affordable alternative to the brand-name drug. Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product. The development of biosimilars can increase access to life-saving treatments for patients who may not be able to afford the brand-name version.
Under the terms of the partnership, Alvotech will be responsible for the development and manufacturing of the biosimilar, while Dr. Reddy’s will handle the commercialization and distribution of the product. The partnership will leverage Alvotech’s expertise in biosimilar development and Dr. Reddy’s experience in commercializing complex generic products.
The biosimilar market is expected to grow significantly in the coming years, driven by the increasing demand for affordable alternatives to biologic drugs. Pembrolizumab is one of the top-selling cancer drugs in the world, and a biosimilar version could potentially disrupt the market and provide significant cost savings to patients and healthcare systems.
Alvotech and Dr. Reddy’s plan to submit their biosimilar application to regulatory authorities in the United States, Europe, and other countries. The companies expect to initiate clinical trials for the biosimilar in the near future and anticipate regulatory approvals in the next few years.
The partnership between Alvotech and Dr. Reddy’s is a significant development in the biosimilar space and has the potential to increase access to affordable cancer treatments for patients worldwide. With the growing demand for biosimilars, this partnership is well-positioned to capitalize on the trend and provide a more affordable alternative to the brand-name version of pembrolizumab. The success of this partnership could also pave the way for the development of other biosimilars, increasing competition in the market and driving down prices for patients.