Novartis’ Sandoz Receives Positive CHMP Opinion for Pegfilgrastim Biosimilar

Novartis’ Sandoz announced on a Sept. 21, 2018 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for marketing authorization of Sandoz’s proposed biosimilar to Amgen’s Neulasta (pegfilgrastim).

Pegfilgrastim is a long-acting form of filgrastim, a biosimilar that stimulates the production of white blood cells and stem cells. Sandoz is seeking approval for use of biosimilar pegfilgrastim in the same indication as the reference medicine to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy. 

Febrile neutropenia is a serious and life-threatening condition that can develop in people with cancer who receive chemotherapy. According to Sandoz, despite treatment advances, febrile neutropenia may pose risks to a person's chemotherapy treatment plan, with consequences such as dose reductions, discontinuation of treatment, or changing to a less effective regimen.

Sandoz reports that the comprehensive data package, submitted as part of the marketing authorization application, includes analytical, preclinical, and clinical data, which demonstrate that Sandoz’s pegfilgrastim matches the reference medicine in terms of safety, efficacy, and quality.

"While pegfilgrastim is a proven effective and safe treatment for febrile neutropenia-related infections, many cancer patients throughout Europe are not treated with this medicine,” said Mark Levick, MD, PhD, global head of development, Biopharmaceuticals, Sandoz, in a company press release. “If approved, we will do our best to provide this critically-important option to all patients who stand to benefit from it."  

The European Commission (EC) takes binding decisions on the authorization of medicines valid throughout the European Union (EU). It bases its decisions on scientific assessments by the CHMP, ensuring that medicines comply with high quality, safety, and efficacy standards. If approved by the EC, the centralized marketing authorization will be valid in the 28 countries that are members of the EU. Norway, Iceland, and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions based on the EC's recommendation.

Sandoz currently has five marketed biosimilars and seven approved biosimilars in Europe. In May 2018, Sandoz received a complete response letter (CRL) from FDA in response to the biologics license application (BLA) for the company’s proposed rituximab biosimilar, which references Roche’s Rituxan/MabThera (rituximab). Rituximab made CHF 7.3 billion (US$7.8 billion) globally in 2017 sales. The reason(s) behind the CRL were not disclosed.

In June 2017, Sandoz’s rituximab biosimilar was approved by the EC in all indications.

In September 2018, Novartis announced it agreed to sell selected portions of its Sandoz United States portfolio, specifically the Sandoz US dermatology business and generic US oral solids portfolio, to generic pharmaceutical company Aurobindo Pharma USA, for $900 million in cash plus $100 million in potential earn-outs. According to Novartis, this transaction supports Sandoz’s strategy of focusing on complex generics, value-added medicines, and biosimilars to achieve sustainable and profitable growth in the US over the long-term.

Source: Novartis