First Generic Version of Navelbine Launched in Europe for Breast, Lung Cancers

First Generic Version of Navelbine Launched in Europe for Breast, Lung Cancers

Lotus Pharmaceuticals has launched the first generic version of Pierre Fabre’s Navelbine (vinorelbine) in soft capsule form in Europe for the treatment of advanced breast cancer and advanced non-small-cell lung cancer, the company has announced.

Vinorelbine soft capsules are now being marketed across Europe, including in France, Germany, Hungary, Italy, Portugal, Romania, Spain, and the United Kingdom.

“We are proud to be the first and the only approved generic in the market as it has always been our commitment to offer affordable alternatives to cancer patients,” Robert Wessman, chairman of Lotus, a subsidiary of Alvogen, said in news release.

The product is fully bioequivalent to Navelbine, allowing patients to access a therapeutic agent with proven anti-tumor activity at a much lower price. Available in 20, 30, and 80 mg, the soft capsules should be swallowed whole — not sucked or chewed — with water and food, and should be stored in the fridge to maintain their therapeutic activity.

“We have a strong history of creating important access to high-quality generic medicine and we’re excited to lead the commercialization of this important product in Europe,” Faysal Kalmoua, executive vice president of Alvogen’s global portfolio, said in another news release.

“Vinorelbine softgel is another prime example of a complex oral oncology product successfully developed by Lotus pharmaceuticals,” he added.

Lotus requested marketing approval of the generic version of Navelbine through multiple decentralized procedures in October 2017 so it could be sold across different European countries.

Completion of the regulatory process was confirmed in March 2019, upon review and confirmation of the generic medicine’s safety and its therapeutic similarity to the branded product.

Vinorelbine is a semisynthetic derivative of the anti-cancer therapy vinblastine, which works as a chemotherapeutic agent to prevent cancer cells from proliferating and spreading. It is indicated for the treatment of locally advanced breast cancer that has spread to nearby tissues and lymph nodes, and metastatic breast cancer (which has spread to distant regions in the body).

It is available as an injectable formulation and as softgel capsules, which are marketed mainly in Europe and Asia.