No sector of the health care industry gets more public, patient, provider, payer and regulatory scrutiny than does the pharmaceutical sector. Yet, drug spending increases are down and new drugs are being developed to treat infectious diseases and chronic medical illnesses. Eight new reports, surveys and published research articles document this challenging competitive landscape for drug makers.


Patent expirations will open $100 billion biosimilar market by 2020

That’s according to a biosimilar market report from GBI Research. In its report, GBI said the average price for a year-long branded biologic medication prescription is $16,425. The average annual price for a biosimilar version is up to 50 percent less, the report said. Some $100 billion in branded biologics will lose patent protection by 2020, opening up the market for biosimilar versions, GBI said. “The biosimilar pipeline is robust, and most products are being developed for the oncology and immunology therapy areas,” the report said. “Over 126 companies are currently involved in biosimilar development, which reflects the significant commercial potential that these products represent.”

Researchers say widespread use of biosimilars for chronic diseases must overcome three challenges

Biosimilar versions of branded biologic medications for chronic illnesses have great potential to treat patients at less cost, but only if they overcome three challenges. That’s according to researchers who published their thoughts in the Journal of the American Medical Association. Researchers said among the barriers is the likely requirement that physicians will need to write new prescriptions to have patients switch from biologics to biosimilars unlike generic substitutions, which are automatic and require no new prescription.

Clinical Trials

82% of pharmaceutical companies conducted observational drug studies in 2016

That’s according to a survey of drug manufacturers by Cutting Edge Information. That’s a slight rise from the 79 percent of drug makers surveyed by the firm in 2015. “Observational trials allow pharmaceutical companies to gather valuable, descriptive real-world data,” the firm said. “Companies use these post-marketing studies to gather information related to product usage patterns, cost-effectiveness and long-term effectiveness.” Still, 60 percent of the observational studies done last year included retrospective data as part of their design, the report said.

Eight drug companies working on vaccines for 35 infectious diseases

That’s according to a report from the Access to Medicine Foundation. In its report, the advocacy group lauded drug makers for launching 89 separate clinical trials to develop new vaccines or adapt existing ones to immunize patients from the 35 diseases. The six diseases receiving the most research are: pneumococcal disease, HPV, seasonal influenza, meningococcal disease, RSV and dengue. However, the group noted that another 34 infectious diseases have no vaccines and are not the subject of any clinical trials. The report said the global vaccine market grew to $33 billion in 2014 from $6 billion in 2000.

Drug Spending

Increase in drug spending slowed to 5.8% in 2016

That’s less than half of the 12.4 percent increase in drug spending in 2015, according to the latest annual report from the QuintilesIMS Institute. Total spending on prescription medications on an invoice-price basis reached $450 billion last year, up from $425.3 billion in 2015 and $378.5 billion in 2014. After off-invoice discounts, rebates and other price concessions, net spending on prescription medications grew just 4.8 percent last year to $323.1 billion, the report said.

Price increases for prescription medications also slowed in 2016

Prices for prescription medications rose 8.8 percent last year, according to the latest annual National Drug Index published by Truveris, a New York-based drug benefits technology firm. That’s down from the 10.4 percent increase reported by the company in 2015. Breaking down the price increase by drug type, Truveris said the price of branded prescription medications rose 12.9 percent last year, 7.9 percent for specialty drugs and 0.3 percent for generic drugs.

Oncology Drugs

FDA approved 53 new cancer drugs between 2011 and 2015

The FDA approved 53 new drugs to treat cancer and hematologic diseases from 2011 through 2015, according to a report in the New England Journal of Medicine. Researchers said oncology and hematologic drugs were the largest therapeutic category of 170 prescription medications approved over that five-year period. Tied for second with 25 new agents each were drugs for cardiovascular disease, diabetes mellitus and hyperlipidemia and drugs to fight infectious diseases. The balance—67 agents—were for all other disease categories. The median total review time for the 170 approved drugs was 306 days. By comparison, the European Medicines Agency blessed 144 new drugs with a median total review time of 383 day over the same five-year period.

National Cancer Institute launches formulary to improve access to new cancer drugs

The National Institutes of Health’s National Cancer Institute created a drug formulary that the agency said will improve patient access to oncology drugs under development. “The NCI Formulary will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner,” the NCI said in a statement. Medical researchers and clinicians at NCI-designated cancer centers will have access to 15 approved and investigational cancer drugs from six pharmaceutical manufacturers that the researchers and clinicians can use in preclinical studies and clinical trials, the NCI said.

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