Positive CHMP Opinion for 2 Brands of Fresenius Kabi's Adalimumab Biosimilar
February 4th 2019On Friday, Fresenius Kabi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for its MSB11022, a biosimilar adalimumab referencing Humira. The CHMP issued its opinions for the marketing of 2 brand names of the drug: Idacio and Kromeya.
Drug Pricing Forecast Reminds Stakeholders About Role of Biosimilars
February 2nd 2019A raft of biosimilars possibly coming to market is not expected to relieve the burden of healthcare costs in 2019, but it is possible that the combination of products in the queue, as well as reimbursement changes, could be the beginning of change, according to a drug pricing forecast out this week from Vizient.
An End to the Rebate Trap? HHS Proposes Rule to End Safe Harbor
February 1st 2019On Thursday, HHS proposed a rule intended to reduce patients’ out-of-pocket costs for prescription drugs by blocking rebates and discounts given to pharmacy benefit managers, Part D plans, and Medicaid managed care organizations and encouraging discounts given directly to patients.
Biosimilar Education Roundup: January 2019
January 31st 2019While the body of reassuring data on the safety and efficacy of biosimilars continues to grow, worrisome information about stakeholders’ levels of awareness of these products is also coming to light, and January 2019 saw the publication of a spate of studies showing low levels of patient and provider education on biosimilars.
Innovent Seeks Chinese Regulatory Approval for Proposed Biosimilar Bevacizumab
January 30th 2019Innovent Biologics, a China-based biopharmaceutical company, recently submitted a New Drug Application for its proposed bevacizumab biosimilar, IBI-305, referencing Avastin, to the Chinese regulatory agency, the National Medical Products Administration.
More Research Finds Low Awareness of Biosimilars Among Oncology Providers
January 29th 2019While a majority of survey respondents said that they were at least somewhat familiar with current developments in oncology biosimilars, analyses of open-ended definitions found that only 1 participant could fully define a biosimilar, according to researchers.
Eye on Pharma: Biocon Reports Its Highest-Ever Revenue and Profit Growth for Q3
January 28th 2019In the past year, Biocon received marketing approvals in the European Union for both its biosimilar pegfilgrastim (sold as Fulphila) and its biosimilar trastuzumab (sold as Ogivri), which were co-developed in a partnership with Mylan.
Review Points to Nocebo Effect as a Cause of Higher Discontinuation Rates for Biosimilars
January 28th 2019In observational studies of patients who have switched treatment from a reference biologic to a biosimilar, some higher rates of discontinuation have been observed when these studies are compared with blinded switching studies.
Proposed CMS Changes Are the Wrong Way to Save Money and Will Harm Patients and Providers
January 28th 2019We are acutely aware of the escalating costs of medical therapies in the United States and the critical need to control these costs. However, the best way to control such costs is not by limiting access to rational and appropriate use of the most effective treatments, but rather through other strategies that support comparative effectiveness studies, cost-effectiveness evaluations, and the education of physicians and patients about appropriate use of medical treatments.
Coherus Settles With AbbVie, Sues Amgen, Over Biosimilar Adalimumab
January 28th 2019Coherus BioSciences announced on Friday that it has become the latest biosimilar developer to settle with AbbVie, maker of the brand-name adalimumab, Humira, over a proposed biosimilar. In an intellectual property twist, Coherus also announced that it has sued a rival biosimilar developer, Amgen.
Bio-Thera Begins Phase 3 Trial of Proposed Tocilizumab Biosimilar
January 27th 2019Bio-Thera Solutions, a China-based biosimilar developer, announced that it has dosed the first patients in its phase 3 clinical study of BAT1806, a proposed biosimilar tocilizumab referencing Actemra, an interleukin-6 inhibitor.
Drugs Targeted by Biosimilars Are Responsible for Some of the Highest Hospital Spending
January 25th 2019A new report from research institution NORC at the University of Chicago finds that hospitals and health systems face high annual growth in drug spending, and some of the highest-spend drugs are those facing biosimilar challenges.
Sales of Oncology Reference Products Far Outpace R&D Costs, Study Finds
January 25th 2019Drug makers often point to substantial research and development (R&D) costs as reasons for the high prices of innovator drugs, particularly in oncology. However, some stakeholders have expressed skepticism about whether R&D costs are indeed in line with the prices that drug makers charge. In a new study published in JAMA, investigators sought to compare sales of cancer drugs with estimated R&D costs.
Sanctions Against Samsung BioLogics Suspended Pending Court Ruling
January 24th 2019A South Korean court ruled this week that penalties imposed against Samsung BioLogics, parent company of biosimilar developer Samsung Bioepis, by the Financial Services Commission (FSC) for allegedly committing fraud have been suspended.
Amgen and Allergan Announce Positive Topline Results for ABP 798
January 24th 2019Amgen and Allergan today announced positive topline results of a combined phase 1 and phase 3 study evaluating ABP 798, a proposed biosimilar rituximab, in comparison with the reference Rituxan in patients with rheumatoid arthritis.
Patient Awareness of Biosimilars Impacts Adherence, but Nurse-Led Education Could Help
January 23rd 2019Despite the fact that biosimilars have a longer history in the European Union than in the United States, many European patients still lack awareness of these medicines, and data suggest that a lack of awareness may be keeping patients from adhering to their therapies.
Increased Use of Infliximab Biosimilars Corresponds to Increased Reporting of AEs
January 21st 2019The study investigators noted that the number of individual case safety reports related to infliximab biosimilars increased directly after the marketing availability of the medicines in Italy, which can be interpreted as a result of more patients having access to infliximab therapy.
Canadian Payer Reports a Successful Switch to Biosimilars
January 21st 2019In 2018, Green Shield Canada launched its pilot Biosimilar Transition Program, through 3 plan sponsors, under which patients already receiving biologics were switched to biosimilars. Now that the pilot is complete, the payer is calling the program a success.