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.
This announcement was followed by news that the EMA has accepted its marketing authorisation application for a biosimilar to Pfizer’s EU-licensed Enbrel (etanercept) – a tumour necrosis factor alpha (TNF-alpha) inhibitor used in the treatment of arthritis and psoriasis.
Sandoz says it is seeking approval for all the indications of the reference product, which would offer an alternative treatment option to the more than 120 million people in the EU living with rheumatic and musculoskeletal diseases and approximately 3.7 million Europeans with psoriasis.
The company claims the availability of a more affordable version of the Enbrel blockbuster biologic – which brought in revenues at Pfizer of more than $4.5 billion in 2014 –would increase currently limited patient access.
“Today, only 5% of severe psoriasis patients in North America and Europe have access to life-changing biologic treatment options such as etanercept,” says Mark McCamish, head of global biopharmaceutical and oncology injectables development at Sandoz. “The acceptance by the EMA of our biosimilar etanercept regulatory submission is a move towards enabling more patients with chronic inflammatory conditions such psoriasis and rheumatoid arthritis to be treated with biologics.”
Sandoz has enjoyed a successful year in 2015, becoming the first company to launch a biosimilar product in the US in September with Zarxio, its version of another Amgen drug, Neupogen (filgrastim).
The company plans to make 10 regulatory filings before the end of 2017. Having already announced two, it faces a battle for approval of its etanercept biosimilar in the US, where Amgen currently holds marketing rights.
Amgen secured two additional patents to the drug in 2011, which could prevent biosimilar competition until 2028 or 2029. However, Sandoz is preparing itself for a court challenge, insisting it has “a good faith legal basis to challenge the validity of these patents.”