Sandoz Biosimilars Rituximab and Etarnercept Move One Step Closer to EU Approval

Sandoz Biosimilars Rituximab and Etarnercept Move One Step Closer to EU Approval

Sandoz, a division of Swiss pharmaceutical giant Novartis, welcomed the April 21 decision by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to recommend that biosimilars rituximab and etanercept be accepted in Europe for the same indications as their respective reference medicines.

Biosimilars are biological medical products that are nearly identical to the original product, but manufactured by a different company once the original product expires. They can be manufactured when the patent to the original product expires, and are usually sold at significantly lower prices.

If approved, rituximab may be prescribed for the same conditions as its reference medicine MabThera (marketed in the United States as Rituxan). Those conditions are follicular lymphoma and diffuse large B-cell lymphoma, two subtypes of non-Hodgkin lymphoma, chronic lymphocytic leukemia, and the autoimmune diseases rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis.

Similarly, if the EMA approves the biosimilar etanercept, it may be used for the same indications as Enbrel in the European Union; these include RA, axial spondyloarthritis, juvenile idiopathic arthritis, plaque psoriasis and psoriatic arthritis.

“We are proud to help patients in Europe with blood cancers and immunological diseases by improving their access to effective treatments through the potential approval of not just one, but two new Sandoz biosimilar medicines,” Dr. Mark Levick, global head of development for biopharmaceuticals at Sandoz, said in a press release. “Today’s recommendations from the CHMP will not only benefit patients, but they demonstrate our leadership in biosimilars and the strength of the Sandoz and Novartis immunology and oncology portfolios.”

The CHMP based its recommendations on two development programs that proved the biosimilarity of rituximab and etanercept to their reference medicines.

Biosimilar rituximab was shown to have the same behavior and clinical activity as Mabthera in lymphoma patients, in the ASSIST-FL Phase 3 trial for follicular lymphoma (NCT01419665).

Data presented last December at the American Society of Hematology 58th Annual Meeting & Exposition showed that rituximab plus chemotherapy had a similar objective response rate to the rituximab-chemo combo in previously untreated advanced-stage follicular lymphoma patients.

Safety, pharmacodynamics and pharmackinetics were also similar in both arms, according to the abstract, “Phase III Efficacy and Safety Study of the Proposed Rituximab Biosimilar GP2013 Versus Rituximab in Patients with Previously Untreated Advanced Follicular Lymphoma.”

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