Pharma industry set for bumper 2015
pharmafile | January 5, 2015 | News story | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | 2015, FDA, bumper, harvoni, opdivo, pharma, sovaldi
Industry analysts predict 2015 will be another year of growth for the pharma, after approvals of new drugs soared to record levels in 2014.
Figures show the FDA gave the go-ahead for 41 novel treatments, the highest number of approvals in 18 years.
The FDA’s Center for Drug Evaluation and Research approved 41 novel medicines in 2014, 14 more than in 2013 according to FDA figures. The highest-ever number of approvals was in 1996, when 56 new drugs were approved.
European approvals were also higher than in previous years, and were largely driven by recommendations for new treatments for cancers and rare diseases. The EMA recommended 82 new medicines last year, up from 79 in 2013 and 57 in 2012. Some 17 of these were drugs for rare diseases.
In 2014 nearly 40% of new US approvals were for rare diseases, as the industry continued to focus on highly specialised drugs where competition is often limited and innovative products can command higher prices.
The wave of new drug approvals in Europe and the US suggest the industry is beginning to recover from a string of drug patent expirations on blockbuster products in recent years.
According to industry analysts EvaluatePharma, global sales for the top 10 best-selling drugs are expected to reach $82 billion in 2015. This figure is said to be dominated by Gilead’s hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir), which have predicted combined sales of $15.3 billion.
Several hotly-anticipated drugs are expected to be approved this year, with new biologics for cancer and high cholesterol among industry analysts’ predictions for the biggest 2015 launches and growth in sales across the next five years.
EvaluatePharma predicts that Bristol-Myers Squibb’s Opdivo (nivolumab), a monoclonal antibody that has shown promise as a treatment for multiple myeloma and Hodgkin’s lymphoma, could reach more than $650 million in sales during 2015 alone. BMS has already filed applications in the US and EU, and a decision is expected from the FDA in March.
In cardiovascular disease a new class of lipid-lowering drug, called PCSK9 inhibitors, are expected to gather strong sales – if they are launched this year. Amgen and Astellas have already filed their biologic offering evolocumab, while Sanofi/Regeneron’s competitor drug alirocumab, is in Phase III trials.
As biologic drugs both will cost significantly more than existing lipid-lowering treatments, where generic statins are first choice and guidelines in the UK and the US have recommended expanding the group of patients prescribed statins. Despite this, EvaluatePharma predicts sales of alirocumab and evolocumab to reach $44 million and $77 million in 2015, respectively.
Lilian Anekwe
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