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Non-Hodgkin's lymphoma drug market "will more than double" by 2019
 
 
  pharmatimes World News | May 04, 2011
 
Lynne Taylor
 
Non-Hodgkin's lymphoma drug market "will more than double" by 2019
 
Sales of drugs to treat non-Hodgkin's lymphoma are set to more than double in value over the next decade, increasing in seven major world markets from around $4 billion in 2009 to $8.4 billion by 2019, according to new forecasts.
 
Growth in the seven markets - US, UK, France, Germany, Italy, Spain and Japan - will be driven by the launches of premium-priced therapies, but market development will also be tempered as a result of the introduction of biosimilar versions of rituximab (Roche/Genentech/Chugai Seiyaku/Zenyaku Kogyo's Rituxan/MabThera). These are set to commence in Europe during 2013, followed by launches in the US in 2015, according to the study, published by Decision Resources.
 
Biosimilar versions of rituximab will be available at lower prices than the branded product, says the report, which adds that, as a result of the widespread uptake of the product across all non-Hodgkin's lymphoma populations, the entry of biosimilar versions will cause a significant decline in sales of the branded product.
 
Nevertheless, despite the entrance of biosimilars, rituximab will maintain its dominance as the market-leading agent in the period to 2019, forecasts Decision Resources director Andrew Merron.
 
He also points out that, as it attempts to reduce the negative impact of biosimilar erosion on its branded product, Roche has developed a novel anti-CD20 antibody - GA-101- plus a subcutaneous formulation of rituximab that should help soften the anticipated drop in sales of the branded, intravenously-delivered product.
 
Little in the way of new commercial opportunity remains for rituximab in the treatment of non-Hodgkin's lymphoma; however, the product's sales will increase to 2014 as its uptake continues to grow in the first-line maintenance setting for follicular lymphoma and as a single agent for newly-diagnosed asymptomatic follicular lymphoma, according to Decision Resources.
 
It also forecasts that sales of GlaxoSmithKline/Genmab's Arzerra (ofatumumab) will increase as a result of greater use in the wider non-Hodgkin's lymphoma patient population, while Celgene's Revlimid (lenalidomide) - an agent which is already widely used in multiple myeloma - and two novel kinase inhibitors - Pharmacyclics' PCI-32765 and Calistoga Pharmaceuticals' CAL-101 - are generating excitement among key opinion leaders. Together, they will contribute to significant sales growth in the non-Hodgkin's lymphoma drug market, following their expected launches beginning in 2014, it says.
 
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Novartis' Rituxan biosimilar goes into Phase II
 
World News | January 11, 2011
 
Kevin Grogan
 
Novartis has begun a mid-stage study for a biosimilar of Roche's blockbuster monoclonal antibody Rituxan/MabThera.
 
The Swiss major's generic unit Sandoz said the Phase II trial for its version of Rituxan (rituximab) is focusing on patients suffering for rheumatoid arthritis. The drug is also approved for other conditions, including non-Hodgkin's lymphoma.
 
Sandoz says that over the past few years it has developed "a robust, high-yield and large-scale process for the production of biosimilar rituximab" at its facilities in Schaftenau, Austria. To ensure biosimilarity with the reference product, "a comprehensive physico-chemical and functional analysis of the product was conducted using modern bioanalytic techniques, followed by further studies". Data so far suggest that its version is "highly similar to the reference product, justifying initiation of clinical studies in patients".
 
Rituxan is a huge earner for Roche, and Novartis says it ranks among the top three biologics worldwide, with 2009 sales of $5.60 billion. Sandoz boss Jeff George noted that this "key development milestone" demonstrates that the firm is on track to maintain its global leadership position in biosimilars in the medium to long term.
 
He added that with "nearly 50% market share within the global regulated biosimilar market, and with three marketed products, Sandoz plans to continue to broaden patient access to essential high-quality biologics". Ameet Mallik, head of Sandoz Biopharmaceuticals, noted that "our pipeline is particularly focused on mAbs, the largest and fastest-growing segment of the biologics market".
 
Other companies are working on a biosimilar of Rituxan, notably Teva Pharmaceutical Industries, while last week Spectrum Pharmaceuticals signed a pact with Viropro to develop a version of rituximab ahead of its US patent expiration in 2015.
 
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Spectrum plans to develop biosimilar Rituxan
 
World News | January 06, 2011
 
US drugmaker Spectrum Pharmaceuticals has said it plans to develop a biosimilar version of Roche and Biogen Idec's cancer and arthritis drug Mabthera/Rituxan (rituximab), with the help of Canadian partner Viropro.
 
While specific financial aspects of the agreement have not been revealed, Viropro said it is a "multimillion" dollar contract and that it stands to receive milestone payments over a period of three years, as well as royalties on eventual sales.
 
Rituxan is Roche's second biggest-selling product with sales of almost $6 billion a year in indications including non-Hodgkin's lymphoma, chronic lymphocytic lymphoma and rheumatoid arthritis. In the past Roche has claimed patent protection for the drug until at least 2015 and possibly 2018 in the USA and 2013 elsewhere, and Spectrum has indicated only that it plans to enter the market on "patent expirations for rituximab over the coming years."
 
The US cancer specialist has no heritage in biosimilars. Its two commercialised products were bought-in from other companies, and it has a pipeline of novel oncology drugs both developed in-house and in-licensed. It can however offer specialist sales and marketing network in oncology, while Viropro brings its expertise in cell culture and bioprocessing technologies to the alliance.
 
Indeed, Viropro has made no secret of its desire to find commercial partners for its biosimilar cell lines and manufacturing processes, and its president and chief executive Dr. Rajiv Datar said the Spectrum alliance was "an important breakthrough for us in the North American market."
 
The announcement comes a few months after Israeli generics giant Teva Pharmaceutical Industries said it had started clinical testing of its own biosimilar version of rituximab.
 
Teva is expected to put in a strong bid in the emerging biosimilar market given its two-year-old alliance with contract manufacturer Lonza. That said, Spectrum would likely have to capture only a small percentage of Rituxan's market share in order to recoup a healthy return on its investment.
 
With over $30 billion-worth of biologic drugs losing patent protection within the coming years, analysts have estimated that biosimilars could quickly become a $10 billion category.
 
A number of biosimilar products are already in the market in Europe, notes Spectrum, and since the enactment of the Biologics Price Competition and Innovation Act of 2009 an abbreviated approval pathway for biosimilars has been created in the USA.
 
 
 
 
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