LONDON, 1 June (APM) - A European biosimilar of the world's biggest-selling drug, AbbVie's Humira (adalimumab), is set for launch in the coming months after the European Medicines Agency on Friday said it is backing Sandoz's version.
Novartis' Sandoz said in an emailed statement that the CHMP opinion recommends marketing approval for its adalimumab for the treatment of all indications of its reference medicine including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis.
Kavya Gopal, head of specialty at Sandoz UK, said: “This significant announcement from the CHMP moves us one step closer to gaining marketing authorisation for our adalimumab biosimilar in the UK, and helping patients with autoimmune conditions to manage their health.
"Biosimilars offer the NHS the potential to lower the cost per patient of using biologic treatments, facilitating responsible caretaking of our health system’s budget. The NHS currently spends over £500 million a year on adalimumab and it is estimated that availability of biosimilars may help the NHS achieve anticipated savings of £300 million a year."
Sandoz’s biosimilar adalimumab, if approved by the European Commission, will not be available in the UK before 16 October, the Swiss generics group said.
The CHMP said the proposed brand names for the adalimumab biosimilar are Halimatoz, Hefiya and Hyrimoz. AbbVie has previously said it expects Humira to remain free of competition until 2023 (APMMA 56620). Humira generated $4.7 billion in this year's first quarter.
Milan said in March it is looking to launch a biosimilar of Humira in Europe in October this year. (APMMA 57121)
Pfizer's Herceptin biosimilar
Pfizer's biosimilar of Roche's Herceptin (trastuzumab) Trazimera has been recommended for HER2-positive metastatic breast cancer and for patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.Roche's Herceptin was first approved in Europe in August 2000. Two biosimilar versions, Celltrion's Herzuma (APMMA 56877) and Merck Sharp & Dohme's Ontruzant (APMMA 55674), are already authorised in the EU, and a third, Amgen/Allergan's Kanjinti, was recommended by the CHMP in March (APMMA 57450).
Nityr
The CHMP is also recommending Cycle Pharmaceuticals' Nityr, a generic of Sobi Orfadin's (nitisinone) for hereditary tyrosinemia type 1.Nityr will be available as 10 mg tablets. The active substance of Nityr is nitisinone, an inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase (HDDP), an enzyme involved in tyrosine degradation, the EMA said.
Orfadin was approved in February 2005.
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