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UK launch of two Novartis biosimilars could cut NHS costs

Sandoz, a division of Swiss pharma giant Novartis, has revealed that two of its biosimilars – Rixathon (biosimilar rituximab) and Erelzi (biosimilar etanercept) – are now available in the UK for use in Europe. Both new medicines have been proven to be non-inferior to their reference products, MabThera and Enbrel, respectively.

Sandoz biosimilars as safe and efficacious as originators, says early trials data

Sandoz, a division of Novartis, has presented data at the Annual European Congress of Rheumatology (EULAR 2016) demonstrating the safety and efficacy of their biosimilar versions of autoimmune disease treatments, Enbrel (etanercept) and Mabthera (rituximab).

In both early stage studies, the Sandoz biosimilars achieved pharmacokinetic bioequivalence with no clinically meaningful differences in safety, tolerability and immunogenicity to the originator.

Amgen raises 2016 outlook after Q1 earnings boost

Amgen (NASDAQ: AMGN) has upgraded their 2016 outlook after posting an increase of 10% in revenues for the first quarter of the year.

7% of product sales growth was driven the likes of arthritis drug Enbrel (etanercept), anaemia medicine Aranesp (darbepoetin alfa) and multiple myeloma drug Kyprolis (carfilzomib). In the case of Kyprolis, sales increased by 43%.

Other high performing drugs driving Amgen’s revenue rise was Neulasta, whose sales topped $1.1 billion worldwide, and Prolia, whose sales rose 29%.

Samsung beats pharma to develop first EU-approved Enbrel biosimilar

Samsung Bioepis
Engineers at the Samsung Bioepis R&D Centre (Photo: Business Wire)

Samsung Bioepis – the collaboration between Samsung Biologics and Biogen Idec, has become the first company to have a biosimilar version of Enbrel approved by the EMA.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, meaning a European Commission (EC) approval for Benepali, a copycat version of Enbrel (etanercept) is likely.

Baxalta’s Enbrel biosimilar measures up in late-stage study

Baxalta logo

Having emerged from its mega-merger deal with Shire, Baxalta is back on its drug development day job – and has announced its Enbrel biosimilar met its primary endpoint in a comparison study with Pfizer and Amgen’s blockbuster.

The Phase III trial found CHS-0214, a proposed biosimilar of Enbrel (etanercept), met its primary endpoint in an ongoing study to evaluate its efficacy and safety compared to Enbrel. The drugs are being trialled in patients with moderate-to-severe rheumatoid arthritis that is inadequately controlled with methotrexate alone.

Sandoz announces biosimilar successes

EMA inside
Sandoz has submitted its biosimilar version of Pfizer's Enbrel to the European Medicines Agency

Novartis’ biosimilars division Sandoz has announced progress in its biosimilars programme, with its version of Amgen’s Neulasta proving as effective as the reference product, and its version of Pfizer’s Enbrel submitted to the EMA.

Sandoz’s biosimilar Neulasta (pegfilgrastim) was found to be effective in a Phase III study of the prevention of neutropenia in patients with breast cancer. It demonstrated a similar safety profile to that of Amgen’s original, according to study data presented at the American Society of Haematology (ASH) annual meeting in Florida.

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