On the Strength of a Discount and Biosimilar Trastuzumab Savings, NICE Recommends Pertuzumab
February 15th 2019The United Kingdom’s National Institute for Health and Care Excellence (NICE) today released a final appraisal of pertuzumab (Perjeta) together with intravenous trastuzumab and chemotherapy for the treatment of HER2-positive early breast cancer, and recommended pertuzumab for use in patients if they have lymph node–positive disease and if drug maker Roche adheres to its promised discount for the drug.
Even as Russian Biosimilars Advance, Providers Have a High Unmet Educational Need
February 15th 2019Even as developers begin work on the next wave of cost-saving biosimilars, and though approximately 50 biosimilar products (including monoclonal antibodies) have been approved in Russia to date, the country has not yet established clear regulatory guidelines for biosimilars.
FDA Proposes Path for Voluntary Pharmaceutical Quality Standards
February 14th 2019The FDA this week announced draft guidance that would allow stakeholders to propose pharmaceutical quality standards for potential informal recognition to increase efficiency in drug development by achieving “voluntary consensus standards.”
As Biosimilars Close In, Innovator Biologic Developers Forge New Strategies
February 14th 2019As brand-name biologics that have achieved strong sales begin to age, and as biosimilar developers grow closer to gaining approval for and launching their products, innovator biologic developers are taking on new strategies to defend their profits and market share.
CT-P13 in IBD Is Safe and Effective in the Long Term, Research Shows
February 14th 2019Evidence to support treating inflammatory bowel disease (IBD), a category that includes Crohn disease and ulcerative colitis, with biosimilar infliximab continues to develop, and several new studies highlight the safety and efficacy of long-term treatment with CT-P13 (Inflectra, Remsima).
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.