Prior Authorization Process Continues to Weigh On Providers and Patients, AMA Says
February 13th 2019An American Medical Association survey of 1000 physicians regarding the impact of prior authorization (PA) found that most providers reported a significant or negative impact on patient care, and more than a quarter reported a serious adverse event.
New Research Highlights the Role of Biosimilar Etanercept in Treating Ankylosing Spondylitis
February 13th 2019While the United States continues to await the launch of the first FDA-approved biosimilar etanercept (Erelzi), in other parts of the world biosimilars of the reference etanercept (Enbrel) are being widely used in clinical practice, and recent research reports on the role that biosimilar etanercept plays in the treatment of ankylosing spondylitis (AS).
Infliximab Saves on Short-Term Costs in ASUC, and Biosimilars Could Help
February 12th 2019Acute severe ulcerative colitis (ASUC) can occur in up to 25% of patients with UC. Salvage therapy with infliximab or cyclosporine is standard first-line therapy for patients who do not respond adequately to intravenous corticosteroids, but questions have arisen about the cost-effectiveness of this approach versus early colectomy. A recent study, conducted in a tertiary hospital network in Australia, sought to compare healthcare utilization and costs between patients with ASUC who had early colectomy and those who were treated with infliximab.
In a Win for Boehringer Ingelheim, AbbVie Must Turn Over Humira Documents
February 12th 2019In a long-running patent dispute with biosimilar developer Boehringer Ingelheim, AbbVie, maker of the brand-name adalimumab, Humira, has been ordered to produce documents related to its efforts to obtain patents that could shield its blockbuster drug from biosimilar competition.
2019: The Year that Interchangeability Might Change the Biosimilars Landscape
February 12th 2019This year, the biosimilar landscape will likely focus on interchangeability as biosimilars manufacturers and other stakeholders seek to reduce costs and increase uptake. This follows the 2018 trend of biosimilar litigation settlements and the attention in 2017 to the information exchanges, also known as the “patent dance,” laid out in the Biologics Price Competition and Innovation Act of 2009.
Phase 3 Study Finds Therapeutic Equivalence Between Pegfilgrastim and Withdrawn Biosimilar Candidate
February 11th 2019Drug maker Gedeon Richter’s RGB-02 is undergoing development as a proposed biosimilar to the reference pegfilgrastim, Neulasta, and researchers recently reported on the results of a phase 3 clinical study of the drug versus its reference in patients with breast cancer who were receiving chemotherapy.
Eye on Pharma: Samsung Bioepis to Partner With C-Bridge on Biosimilars
February 11th 2019Biosimilar developer Samsung Bioepis, a partnership between Samsung BioLogics and Biogen, has announced a new licensing agreement with the private equity firm C-Bridge Capital that will allow the drug maker to expand its reach into mainland China.
Medicare Part D Policy on Off-Label Treatments Thwarts Patient Access, Study Says
February 9th 2019A recent study examining Medicare Part D reimbursement policies for off-label uses, using dermatology as a focus, found that health coverage decisions have significant shortcomings that could hamper patient access to evidence-based treatments.
FDA Releases Final Guidance on Immunogenicity Testing for Biologics and Biosimilars
February 8th 2019The FDA recently released final guidance on the use of therapeutic proteins in developing biologics and biosimilars. "Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection" represents current FDA thinking about developing and validating assays for anti-drug antibody (ADA) detection.
Court Rules That Momenta's Abatacept Appeal Is Moot
February 8th 2019This week, the United States Court of Appeals for the Federal Circuit found that Momenta lacked standing to appeal a decision upholding a patent covering abatacept (Orencia) and said that Momenta’s appeal was rendered moot by the drug makers’ choice to stop developing its biosimilar.
No Safety Risks Found in a Switch From Reference Rituximab to GP2013
February 8th 2019GP2013, a biosimilar rituximab developed by Sandoz and licensed in the European Union under the brand names Rixathon and Riximyo, is used to treat both malignant and inflammatory diseases. A recently published paper, appearing in Arthritis Care and Research, says that researchers detected no safety risks when switching patients with rheumatoid arthritis from reference rituximab (Rituxan) to the biosimilar.
Could Aptamers Be a New Feature in the Biosimilar Developer's Toolkit?
February 6th 2019One emerging method to monitor potential differences is to apply aptamers: single-stranded DNA or RNA oligonucleotides. Aptamers can bind to various targets, and because they have a defined fold that can recognize a target with high affinity, they can be used as surrogate antibodies.
Paper Questions Utility of DANBIO Results for Switching to Biosimilar Etanercept
February 4th 2019In a newly published correspondence, Italian rheumatology providers called into question whether recently published results from the DANBIO registry can be used to guide non-medical switching from reference etanercept (Enbrel) to biosimilar SB4 (Benpali) in patients with inflammatory diseases.
Providers Not Using Part B Drugs to Add to Profit, Research Finds
February 4th 2019The assumption that Medicare Part B payment rates lead providers to create higher drug utilization for costlier treatments in order to benefit from larger add-on payments is not correct, a recent white paper said. The paper from Xcenda, a part of AmerisourceBergen, also found similar results when looking at physician-administered drugs in the hospital outpatient setting.
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.