According to a story from drugs.com, the pharmaceutical company Pfizer, Inc. recently issued an announcement detailing the approval of its drug Ruxience (rituximab-pvvr), a biosimilar to the widely used monoclonal antibody Rituxan (rituximab) in certain indications. The US Food and Drug Administration (FDA) has approved Ruxience for use in patients with microscopic polyangiitis, non-Hodgkin’s lymphoma, granulomatosis with polyangiitis, and chronic lymphocytic leukemia.
About Biosimilars
Biosimilars are similar in function to generic drugs and can be introduced to the market once the patent expires on the original medication or medical product. They are very nearly an identical copy of the original product that is manufactured by another company. Biosimilars are intended, like generics, to offer a cheaper treatment option for patients while receiving the same therapeutic benefit as the more expensive name brand drug. Typically, biosimilars are priced at around 65 to 85 percent of the original drug. To be approved, biosimilars must have no clinically significant differences in safety or efficacy when compared to the original drug.
About Rituximab
Rituximab was one of the very first monoclonal antibody drugs to be approved and it has proven itself to be widely capable in treating a number of rare diseases, particularly a variety of cancers and autoimmune diseases. It is an effective component of treatment for many cancers that affect white blood cells. The drug has at time been used off-label to treat autoimmune diseases, though it is also an approved treatment for some of them. Rituximab works by targeted a protein called CD20 which appears on the surface of B cells.
It is important for biosimilars of such a largely successful drug to be available, and the approval of Ruxience is just one of several biosimilars for rutiximab that has been made available over the years. Ruxience is the third cancer drug biosimilar that has gained approval so far this year, signaling an increased willingness from the FDA to improve drug access for patients with severe disease.
With this new biosimilar, patients suffering from the approved indications will have a better chance of accessing the treatment that they need.
