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Sandoz says Humira biosimilar clears clinical hurdle

Its drug matches the safety and efficacy of AbbVie’s plaque psoriasis blockbuster

Sandoz

Novartis' generics unit Sandoz chalked up a second piece of positive news for its biosimilars unit this week, with positive clinical data for its version of AbbVie's $14bn blockbuster Humira.

The new data - from a 51-week study which shows that Sandoz' drug matched the safety and efficacy of Humira (adalimumab) in plaque psoriasis - comes just after the FDA started its review of the company's biosimilar version Roche's immunotherapy drug Rituxan (rituximab), another blockbuster with sales of $4bn in the first half of the year.

The new data, presented at the European Academy of Dermatology and Venereology (EADV) in Geneva, Switzerland, showed that Sandoz' drug matched the reference medicine throughout the study, with almost 80% of patients experiencing a 75% improvement in symptoms by the end of the trial.

Sandoz says it has already filed for approval of its Humira biosimilar in the EU, seeking a green light to sell its drug as a cheaper alternative to AbbVie's blockbuster in several immunological diseases, including psoriasis, rheumatoid arthritis and inflammatory bowel disease.

The company is playing catch-up in the biosimilar Humira market, with Samsung Bioepis granted approval from the EMA for its Imraldi rival last month and Amgen getting the nod from the FDA for its Amgevita version in March.

Meanwhile, in the US where Sandoz is yet to file because of manufacturing capacity issues, Boehringer Ingelheim has just picked up an FDA approval for its biosimilar Cyltezo, while Amgen got the go-ahead for its product - known as Amjevita in the US market - in September 2016.

Sandoz has indicated it intends to file the drug with the FDA before the end of the year, and as it stands claiming a later approval would not be an impediment as AbbVie is claiming patent protection for Humira until 2022 and neither of the approved products have yet to be launched 'at-risk' of a potentially costly damages suit as patent infringement proceedings play out.

"Patient access to often critical and expensive biologic medicines is one of the key challenges facing healthcare systems in developed economies today," said Mark Levick, Sandoz' head of biopharma development.

"Biosimilars are fundamentally changing the ability of healthcare systems to address this challenge," he added.

Article by
Phil Taylor

14th September 2017

From: Research

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