Spectrum Pharmaceuticals and Viropro will work together to develop a biosimilar of Roche/Genentech’s rituximab. The mAb therapeutic made $5.6 billion in worldwide sales during 2009. Patents covering various uses are expected to start expiring from October 2014.
Rituximab targets the CD20 protein and is approved as a treatment for chronic lymphocytic leukemia, non-Hodgkin lymphoma (NHL), and rheumatoid arthritis. In NHL it is used a first-line, second-line, and maintenance therapy. The mAb is marketed in Europe as MabThera by Roche and in the rest of the world as Rituxan by Biogen Idec and Genentech, except for Japan where it is co-marketed by Chugai and Zenyaku Kogyo.
In April 2007, Dr. Reddy’s Laboratories launched its own version of rituximab called Reditux in India. The company has said that it plans to market Reditux outside India including the U.S. once the product’s patent expires in 2015.
Spectrum Pharmaceuticals is an oncology-focused company with two marketed drugs: Fusilev (osteosarcoma) and Zevalin (NHL and follicular B-cell NHL). It has two drug candidates, apaziquone and belinostat, in late-stage development. Apaziquone is being studied for intravesical instillation in non-muscle invasive bladder cancer. Belinostat is being developed as a treatment for peripheral T-cell lymphoma, carcinoma of unknown primary, and other cancers.
The healthcare reform bill passed last year by President Barack Obama included legislation that provides a pathway for getting biosimilars approved. Under the Biologics Price Competition and Innovation Act original biologic drugs, or reference products, will enjoy a 12-year data exclusivity period, starting the date it is approved.
During this time FDA will not be able to sanction biosimilars through the expedited mechanism in which applicants may skip conducting full-fledged clinical trials. Companies conducting a full set of clinical trials may seek FDA approval through the traditional pathway for biologics, without waiting 12 years.
Biosimilar applications cannot be filed until four years after the approval of the reference product. In contrast, the FDA typically gives traditional pharmaceuticals (new chemical entities) about five years of regulatory exclusivity.
The new law also allows certain biosimilars to be designated as interchangeable with a reference product, which gives pharmacies greater flexibility without needing to involve the doctor. Interchangeable biosimilars at lower prices are expected to be the most successful among biosimilars launches.