Oncology

When Samsung Bioepis’ trastuzumab biosimilar, SB3 (Ontruzant), gained regulatory approval in multiple highly regulated markets, it did so on the strength of a data package including evidence from a phase 3 study in patients with HER2-positive early breast cancer. Later, it became apparent that some of the patients who received the reference product in the phase 3 study had been exposed to lots of Herceptin with a marked shift in relative antibody-dependent cell-mediated cytotoxicity (ADCC) activity.

A recent study suggests that adding rituximab to a high‐dose methotrexate‐based combination chemotherapy could prolong overall survival as well as progression-free survival for patients with primary central nervous system lymphoma, a rare and aggressive form of lymphoma.

A recent study found that rituximab maintenance therapy provides no additional benefit for patients with diffuse large B‐cell lymphoma (DLBCL) who are in complete remission after receiving rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy.

This week, researchers reported updated results from a post hoc subgroup analysis from the adjuvant period of treatment in the biosimilar’s phase 3 trial; these results, say the authors, demonstrate that the biosimilar, used in the adjuvant setting, has comparable efficacy and safety to the reference at 1 year.

In a one-page order filed last week, a panel of judges for the US Court of Appeals for the Federal Circuit denied Genentech’s motion for an injunction that would have blocked Amgen from selling its biosimilar bevacizumab, Mvasi, pending the outcome of an appeal.

This week, a pair of papers detailing the clinical program for the biosimilar appeared in Pharmacology Research and Perspectives.

A recent article described a quality improvement project at the oncology specialty pharmacy unit within the University of Chicago Medicine.

OneOncology, a national partnership of community oncology practices, says that its partner practices have begun treating patients with 2 anticancer biosimilars: Kanjinti, a trastuzumab biosimilar referencing Herceptin, and Mvasi, a bevacizumab biosimilar referencing Avastin.

The fact sheet is being released as Canada awaits the launch of additional anticancer biosimilars.

Mylan and Biocon announced this week that they have launched their biosimilar trastuzumab, Ogivri, in Australia. Ogivri, referencing Herceptin, is the first trastuzumab biosimilar to launch in the Australian marketplace and is listed on the nation’s Pharmaceutical Benefit Scheme.

JCR Pharmaceuticals, together with partner Kissei Pharmaceutical, is currently developing a darbepoetin alfa biosimilar, JR-131, referencing Aranesp. Darbepoetin alfa is used to treat anemia caused by chronic kidney disease or by chemotherapy.

Among the data that supported the biosimilar’s approval was a phase 3 study in patients with advanced nonsquamous non–small cell lung cancer. This week, researchers published detailed findings from that study.

The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.

Samsung Bioepis has announced that the European Medicines Agency (EMA) has accepted for review its market authorization application for SB8, a proposed bevacizumab biosimilar referencing Avastin.

Celltrion formed Vcell Healthcare Limited with Nan Fung Group with the aim of commercializing 3 biosimilars in China.

The first anticancer biosimilars have arrived on the US market. Amgen and Allergan have announced the launch of Mvasi, a bevacizumab biosimilar referencing Avastin, and Kanjinti, a trastuzumab biosimilar referencing Herceptin, in the United States.

Singapore-based Prestige BioPharma announced this week that its HD204, a proposed biosimilar bevacizumab product referencing Avastin, met its primary end point in a phase 1 study evaluating the pharmacokinetics (PK), safety, and immunogenicity of the biosimilar in comparison to its reference.

Spain-based drug maker mAbxience is developing a biosimilar rituximab, RTXM83. Last week, researchers reported findings from a head-to-head study of the proposed biosimilar versus its reference product as a first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL).

With trastuzumab biosimilars expected on the US market soon for HER2-positive breast cancer, an advocacy organization for patients with breast cancer said recently that it wants to provide education about the potential of the medicines to lower costs and provide more treatment options.

The subcutaneously administered trastuzumab contains the same monoclonal antibody as the intravenous formulation at a dose of 600 mg per 5-mL vial, plus a recombinant human hyaluronidase, to be used every 3 weeks. The hyaluronidase is used to increase the permeability of the extracellular matrix, allowing for administration of higher volumes and enhanced absorption of the drug.

The investigators found that the biosimilar and the reference in combination with a subdomain II–targeting antibody had similar in vitro inhibition rates for HER2 and HER3 heterodimerization.

Under the approach used by Kaiser Permanente, say the authors, in which oncologists have salaried incomes and are not reimbursed on a relationship to drug price, far higher generic uptake has been observed.

June 2019 was a busy month for oncology biosimilars, in both the supportive care and anticancer contexts, with regulatory activity and the presentation of reassuring new data.

China-based drug maker Henlius has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for a trastuzumab biosimilar, HLX02, referencing Herceptin.

During last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, researchers presented their interim safety results from the REFLECT study, a prospective, noninterventional, observational, multicenter, open-label study of the biosimilar rituximab Rixathon as a curative therapy with cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with previously untreated CD20-positive diffuse large B-cell lymphoma.

During the 24th European Hematology Association (EHA) Congress, researchers from the European branch of the Severe Chronic Neutropenia International Registry reported on experience with reference granulocyte colony-stimulating factor products and a biosimilar.

The FDA recently approved biosimilar rituximab CT-P10, or Truxima. While the drug is not yet available in the United States, data are accruing for its use in Europe. During last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, 4 groups of researchers reported on real-world data that support the use of the biosimilar in cancer care.

Kanjinti was approved for the treatment of HER2-positive breast cancer and gastric cancer.

During this week’s 2019 American Society of Clinical Oncology Annual Meeting, researchers reported on the cardiac safety of Amgen’s biosimilar trastuzumab, ABP 980 (approved in the European Union under the name Kanjinti), versus the reference trastuzumab, Herceptin.

Multiple biosimilars of pegfilgrastim are available in both the United States and Europe, and the field of competitors to Amgen’s brand-name Neulasta continues to expand. During the 2019 American Society of Clinical Oncology Annual Meeting, 3 research teams shared their findings on biosimilar pegfilgrastim development programs from sponsors Sandoz, Fresenius Kabi, and Gema Biotech.