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Biosimilar Competition is Only One of Several Threats Facing Biopharma Blockbuster Drugs

Tuesday May 8, 2012

By Patti Seymour  (pseymouratbptcdotcom)  

Biopharmaceutical products will dominate the list of top ten best selling drugs in 2012. Abbott Laboratories’ arthritis drug Humira® (adalimumab) is forecasted to become the world’s top selling drug in 2012, followed closely by Johnson & Johnson’s Remicade® (infliximab) and Amgen’s Enbrel® (etanercept). Roche is also a member of this exclusive group, with three anti-cancer drugs, Rituxan® (rituximab), Avastin® (bevacizumab) and Herceptin® (trastuzumab) ranked in the top ten. As described in a recent BPTC report, seven biopharmaceutical blockbusters had sales in excess of $5 billion per year in 2010, with total biopharmaceutical sales exceeding $100 billion. According to the IMS Institute for Healthcare Informatics, global biopharmaceutical spending is forecasted to grow to $200 billion by 2015. This market growth is being fueled by the approval of new products and expansion of therapeutic indications from existing products – Humira just received approval for its seventh indication and Remicade has 16 approved indications! However, the blockbuster status of these drugs is being threatened on numerous fronts.

Several of these top selling products will lose patent protection in the next few years, and biosimilar developers have been ramping up to take advantage of these huge market opportunities. By the middle of this decade, spending on biosimilars is expected to grow to $2 billion from $311 million in 2010. Biopharm companies aren’t ready to cede market share to potential biosimilar competitors, though. Roche recently announced plans to cut the price of Herceptin and MabThera (rituximab) in India and rename them in an effort to gain market share and avoid competition from biosimilars in that country. Roche hopes that the lower prices will increase usage rates in India "at least several-fold higher" than current levels, according to Tuygan Goeker, head of Middle East and Asian markets at Roche. The new product names should create an obstacle to companies seeking to divert the Indian products and resell them at a significant profit in other markets, but this is no guarantee that the drugs won’t be diverted to other markets, as Roche knows all too well.

Roche is dealing with the fall-out from counterfeit Avastin from Turkey making its way into the United States supply chain. According to World Health Organization, less than 1 percent of medicines available in the developed world are likely to be counterfeit. While the threat of counterfeit medicines entering the supply chain in the United States is lower than elsewhere, the temptation for doctors to seek cheaper versions of high cost drugs is increasing, especially for biopharmaceuticals, leading to potentially more counterfeited high value drugs finding their way into the US pharmaceutical supply chain. Doctors may unknowingly purchase inferior or unsafe drugs, as was the case in the most recent Avastin counterfeit incident involving “product” that contained no active ingredient.

Another threat facing these blockbuster products is the potential issuance of compulsory licenses to generic manufacturers as evidenced by the Natco Pharma case. In March, Indian drug company, Natco Pharma, was authorized by the Indian government to make and sell a generic version of Bayer’s patented cancer drug, Nexavar. Roche’s plan to rebrand Herceptin and MabThera in India is considered by many a preemptive move to avoid being compelled under Indian law to allow generic drug makers to produce less-expensive versions of these drugs, a fate that Bayer wasn’t able to avoid. In response to India’s issuance of a compulsory license to Natco Pharma for Nexavar, PhRMA President and CEO John Castellani said, “If countries begin to routinely use compulsory licenses, we could see a ‘race to the bottom’ in which governments in the developing world walk away from their responsibility to support research and innovation in public health. In the absence of the investment made by our members, and the resulting research and development, there would be no generic medicines for the world’s patients.”

While companies are taking proactive measures to protect top selling biopharmaceuticals from biosimilar competition, effective annulment of patent protection through compulsory licensing initiatives coupled with the increased counterfeiting of high value products in emerging markets could pose more insidious threats to biopharmaceutical product companies than the emergence of biosimilars.

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