Biosimilar Rituximabs, and Inotuzumab, Coming to Europe

Zosia Chustecka

Disclosures

April 24, 2017

Two biosimilar versions of the monoclonal antibody rituximab have been recommended for approval in Europe, having been found to be "highly similar" to the reference product, rituximab (MabThera, Roche).

The two new biosimilars are Rixathon and Riximyo (both from Sandoz).

Rituximab, first launched in Europe in 1998, has become a backbone of treatment for non-Hodgkin's lymphoma (NHL) and is also used in chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and granulomatosis with polyangiitis and microscopic polyangiitis (GPA&MPA).

Rixathon is used for all four indications, but Riximyo is not indicated for use in CLL.

The positive recommendation comes from the European Committee for Medicinal Products for Human Use (CHMP). The next step is full approval from the European Medicines Agency (EMA), which usually follows in about 6 weeks.

The EMA notes that rituximab is a monoclonal antibody that binds specifically to the transmembrane protein CD20, found on both malignant and normal B cells. In NHL and CLL, this promotes destruction of malignant B cells and thus controls tumor growth. In RA and GPA& MPA, it reduces B cells involved in their pathogenesis. 

European oncologists have been enthusiastic about the coming of biosimilars. The main attraction is their potential to lower costs.

In a position paper released earlier this year, the European Society for Medical Oncology (ESMO) said that price discounts for biosimilars of 20% to 40% could be reached in Europe, with potential savings for healthcare systems of €50 billion to €100 billion ($53 billion to $107 billion) by 2020.

"Biosimilars are an excellent opportunity to have good, valid drug options that improve the sustainability and affordability of cancer treatment in various countries," Professor Josep Tabernero, chair of the ESMO Cancer Medicines Working Group, from the Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Spain, commented in a statement at the time.

Other biosimilars in oncology expected soon include trastuzumab (reference product, Herceptin) and bevacizumab (Avastin).

New Product for ALL

CHMP also recommended approval for inotuzumab ozogamicin (Besponsa, Pfizer) for the treatment of acute lymphoblastic leukemia (ALL). If the EMA grants full approval within the next 6 weeks, as would be expected, this would be the first approval worldwide for this product.

It is awaiting approval in the United States, where the Food and Drug Administration has assigned it priority review, with a decision expected by August 2017. 

The full indication expected in Europe is for use as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor ALL. In adult patients with Philadelphia chromosome–positive relapsed or refractory B cell precursor ALL, treatment with at least one tyrosine kinase inhibitor should have failed.

Inotuzumab ozogamicin is a humanized IgG4 antibody that specifically recognizes human CD22, the committee notes in its announcement. The agent increases the proportion of patients with ALL who have complete remission and molecular remission and delays the progression of disease, it adds.

The most common adverse effects are thrombocytopenia, neutropenia, anemia, leukopenia, infection, hemorrhage, and venoocclusive liver disease/sinusoidal obstruction syndrome.

Nivolumab for Bladder Cancer

Also recommended for approval was a new indication for the immunotherapy nivolumab (Opdivo, Bristol-Myers Squibb).

The new indication is for nivolumab to be used as monotherapy for locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

This will be the sixth cancer indication for the drug — nivolumab is already approved for use in the treatment of melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin's lymphoma, and squamous cell carcinoma of the head and neck.

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