Novartis starts late-stage biosimilar trials for Amgen drugs
pharmafile | January 19, 2012 | News story | Research and Development, Sales and Marketing | Amgen, Neulasta, Neupogen, Novartis
Novartis has begun Phase III biosimilar trials to copycat two of Amgen’s neutropenia drugs.
The studies, which are being undertaken by Novartis’ subsidiary Sandoz, are studying biosimilars of Amgen’s neutropenia treatments Neupogen (filgrastim) and Neulasta (pegfilgrastim), in the hope of getting them into new markets.
The filgrastim trial will compare the efficacy and safety of Sandoz’s biosimilar filgrastim, against Neupogen in breast cancer patients eligible for myelosuppressive chemotherapy treatment.
Neupogen is licensed to treat neutropenia, a lack of certain white blood cells caused by cancer.
It is expected to support marketing authorisation in the US, one of the few places it is not currently available – it is already marketed under the brand name Zarzio in more than 30 countries outside the country.
The second study is for a biosimilar version of Amgen’s Neulasta, which is licensed to prevent infections due to cancer chemotherapy-induced neutropenia.
The pegfilgrastim study is being conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment, and represents the ‘next major step’ in the Sandoz global biosimilar development programme, according to Novartis.
Sandoz’s global head, Jeff George, said: “Sandoz is already the clear global leader in biosimilars overall and in each of our three marketed products, with approximately 50% total segment share in the highly regulated markets of North America, Europe, Japan and Australia.
“These two development milestones demonstrate that we also continue our efforts to make good on the longer-term promise of our leading pipeline.”
In addition to Zarzio, Sandoz markets biosimilars of the growth hormone deficiency drug somatropin (Omnitrope) and anaemia in chronic kidney failure treatment epoetin alfa (Binocrit), in countries across Europe and elsewhere.
Biosimilars are more difficult to create than other generics, and must go through a similar clinical trials process as new drugs to prove they are as safe and efficacious as the drugs they copy.
This makes the process much longer and more expensive than with generics, but it can be highly lucrative, as there will be little biosimilar competition due to the complexities in manufacturing the drugs.
Ameet Mallik, global head of Sandoz biopharmaceuticals, added: “The start of these two studies represents significant progress for our broad ongoing development program, which includes previously announced late-stage trials for biosimilar rituximab (Roche’s blood cancer and arthritis drug Rituxan).
“We will work to leverage our strong capabilities and our unique position within Novartis to drive the continued success of our biosimilar pipeline, with eight to 10 molecules at various stages of development.”
Ben Adams
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