Medicines in an automated pharmacy

EU Commission grants market authorisation for Sandoz’ Humira biosimilar

pharmafile | July 30, 2018 | News story | Sales and Marketing FDA, Sandoz, approval, biosimilar, european commision 

The European Commission has granted marketing authorisation to Sandoz’ biosimilar Hyrimoz for use in all indications, including rheumatoid arthritis, plaque psoriasis, Crohn’s disease, uveitis and ulcerative colitis.

The Novartis subsidiary Sandoz, gained approval for its anti-inflammatory biosimilar Hyrimoz, which will be available as a 40mg pre filled syringe for treatment of a range of conditions. The drug however, will not be available in the UK before 16 October 2018.

The approval marks Sandoz ’sixth approved biosimilar medicine in Europe and the company’s fourth biosimilar approval in the past 18 months. The recent approval reaffirms Sandoz’ move towards leadership in regards to biosimilar development.

The reference drug which is sold under the brand name Humira was the first monoclonal antibody approved by the FDA and the third TNF inhibitor approved in the United States. While the immunosuppressive medication, which was originally marketed and manufactured by Abbot Laboratories, currently costs $4370 each month in the United States, the NHS spends £500 million a year on Humira. However the branded drug’s patent expired in 2016.

As such the biosimilar may allow for significant savings in both Europe and the United Kingdom. The availability of biosimilars in general could save the NHS up to £300 million each year.

Louis Goss

Related Content

FDA approves ANDA of 20mg generic Nitisinone capsules

Analog Pharma and Dipharma have announced that the US Food and Drug Administration (FDA) has …

FDA approves Pfizer’s RSV vaccine for older adults

Global pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has …

Bristol Myers Squibb’s NDA accepted by FDA

Global pharmaceutical company Bristol Myers Squibb (BMS) has announced that its New Drug Application (NDA) …

Latest content