Review Highlights Biosimilar Epoetin Alfa in Treating Anemia in Myelodysplastic Syndromes
April 23rd 2019Myelodysplastic syndromes, which are a diverse group of neoplasms that arise from hematopoietic stem cells, are characterized by ineffective hematopoiesis, leading to cytopenias such as anemia and neutropenia.
Biosimilars Can Reduce Inequities in Access to Treatment, Study Reports
April 22nd 2019National guidelines and reimbursement rules are likely to be key drivers of disparities; in some countries, biologics are not reimbursed at all, while in others, patients may need to have high disease activity levels, or may need to fail numerous small-molecule drugs before gaining access to biologics. Differences in cost-effectiveness thresholds used in Health Technology Assessments may also be a factor.
WHO Fair Pricing Forum Focuses on Biosimilar Access in Middle- and Low-Income Countries
April 22nd 2019In Johannesburg, South Africa, the World Health Organization (WHO) recently arranged for closed meetings between government representatives, nongovernmental organizations, academics, experts, and the pharmaceutical industry to address concerns regarding fair pricing and patient access to pharmaceuticals, particularly related to middle- and low-income countries. The second Fair Pricing Forum took place from April 11-13, 2019.
As Biosimilars Gain Ground in Canada, Janssen Offers Cheaper Brand-Name Biologics
April 22nd 2019As biosimilars begin to gain ground in the country, Janssen, maker of a number of brand-name biologic products that face current or oncoming biosimilar competition, has launched a program—the Biologics Savings Partnership—that it says will offer patients brand-name biologics at prices similar to those of biosimilar options.
Could Novartis' Brolucizumab Beat Biosimilar Anti-VEGFs in Ophthalmology?
April 20th 2019This week, the FDA granted priority review to Novartis’ innovator biologic, RTH258, brolucizumab. The vascular endothelial growth factor (VEGF) inhibitor is intended to treat wet age-related macular degeneration.
CMS Allows Copay Accumulator Programs to Encourage a Shift to Generic Drug
April 19th 2019CMS’ final 2020 Payment Notice will allow insurers to stop counting the value of manufacturer drug coupons for branded drugs towards a beneficiary’s maximum out-of-pocket costs in order to promote the use of generic drugs.
Judge Grants BI's Motion to Compel AbbVie to Produce Documents in Ongoing Humira Litigation
April 18th 2019This month, US magistrate judge Richard A. Lloret granted Boehringer Ingelheim (BI)’s motion to compel AbbVie to produce prelitigation disclosures and settlements concerning its brand-name adalimumab, Humira.
IGBA Outlines Steps Needed for a Successful Biosimilar Regulatory System
April 17th 2019According to The International Generic and Biosimilar Medicines Association (IGBA)’s paper, despite global progress in strengthening the regulatory system for medicines, progress related to biologics and biosimilars has been less robust.
PBM Says Its Biosimilars Strategy Led to 86% Use of Biosimilar Infliximab
April 17th 2019Magellan Rx Management, a pharmacy benefit manager (PBM), said today that its biosimilar management program has resulted in strong biosimilar uptake and significant drug cost savings for health plan organizations during its first year.
COA Releases Biosimilars Position Statement
April 16th 2019The Community Oncology Alliance (COA) recently released a position statement about biosimilars, saying it will work with stakeholders to support the acceptance of biosimilars as well as work to close knowledge gaps, given the burdensome cost of cancer care.
Updated ASCO and ASH Guidelines on Managing Anemia Support Safety, Efficacy of Biosimilar ESAs
April 16th 2019The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) first published their guidelines on erythropoiesis-stimulating agents (ESAs) in cancer care in 2002, with updates in 2007 and 2010, and the new update is the first to address biosimilar epoetin alfa.
ICER to Review RA Therapies, Including Biosimilar Infliximab
April 16th 2019The new assessment, says the Institute for Clinical and Economic Review (ICER), is intended to incorporate data that have emerged since the organization reviewed rheumatoid arthritis (RA) treatments in 2017, including data related to biosimilar infliximab, Inflectra.
Study Reports on Physiochemical and Biological Characterization of Rituximab Biosimilar RTXM83
April 12th 2019While the United States awaits the launch of its first biosimilar rituximab, other regulatory jurisdictions have biosimilars referencing Rituxan already available on the market. One such product, available in South America, the Middle East, and Africa, is RTXM83, developed by drug maker mAbxience.
Russian Drug Maker Gains World's First Approval for Biosimilar Eculizumab
April 11th 2019Russian drug manufacturer Generium Pharmaceutical, which specializes in orphan drugs, announced yesterday that it has received Russian marketing approval for its biosimilar eculizumab, referencing Soliris, the most expensive orphan drug in Russia.
Reference Infliximab and CT-P13 Show Similar Physicochemical and Functional Stability
April 11th 2019Between reference infliximab and biosimilar infliximab CT-P13 (Inflectra, Remsima), different recommendations exist for the clinical solutions. Recently, a research article, published in BioDrugs, assessed and compared the stability of the solutions prepared from the originator and the biosimilar using a set of characterization methods in line with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use recommendations.
Asian Researchers Report Success With Biosimilars in the Rheumatology Clinic
April 10th 2019During this week’s 21st Congress of the Asia Pacific League of Associations for Rheumatology and Australian Rheumatology Association, held April 8-11 in Brisbane, Australia, multiple groups of researchers are reporting on the real-world use of biosimilars in rheumatology. According to these research teams, biosimilars are proving to be effective in the real-world clinical setting.