2 Studies Show Similar PK, PD for MK-1293 and Originator Insulin Glargine
August 23rd 2017A new paper, accepted for publication in Diabetes, Obesity and Metabolism, describes 2 recent studies that demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity between MK-1293, an insulin glargine follow-on being developed by Merck (who funded the studies), and the originator insulin glargine (Lantus).
Stakeholder Groups Praise Enactment of FDARA
August 22nd 2017Despite earlier White House statements indicating that the Trump administration would ask the FDA to generate 100% of its program funding through user fee programs, on August 18, the President signed the FDA Reauthorization Act of 2017 (FDARA) into law.
Innovator Eculizumab Wins 3 New US Patents, 1 New European Indication
August 22nd 2017Drug maker Alexion has announced 3 new US patents for its eculizumab (Soliris), a first-in-class monoclonal antibody that specifically binds to the complement protein C5. Additionally, the drug gained the European Commission’s approval for the treatment of refractory generalized myasthenia gravis.
Real-World Evidence Shows Biosimilar Filgrastim Safe, Effective Against Febrile Neutropenia
August 21st 2017Febrile neutropenia (FN) is among the most common complications of chemotherapy, and a recent post-marketing, multi-center, real-world, non-interventional, epidemiological study sought to examine the use, safety, and efficacy of biosimilar filgrastim in the primary and secondary prevention of FN.
CVS Health Survey Finds Patients Ready for Cost-Saving Biosimilars
August 19th 2017Pharmacy Benefit Manager CVS Health, which has over 90 million members, has released the results of a survey it conducted of approximately 2000 people in the United States concerning patient perceptions of generic and biosimilar medications.
LA-EP2006 as Effective, Safe as Reference Pegfilgrastim in Asian Patients With Breast Cancer
August 18th 2017Recombinant human granulocyte colony-stimulating factor (G-CSF), filgrastim, and its long-acting pegylated form, pegfilgrastim, are widely used to reduce the risk of chemotherapy-induced neutropenia, but to date, no pegfilgrastim biosimilar has been approved in highly regulated markets such as Europe, Japan, and the United States.
Bevacizumab Biosimilars Could Affect the Value of Systemic Therapy in Gynecologic Cancers
August 17th 2017Treatment guidelines for ovarian and cervical cancer recommend the use of the angiogenesis inhibitor bevacizumab (Avastin), but patient access to this medication and other angiogenesis inhibitors is limited.
Price Deals for Reference Products Pose a Threat to Biosimilars
August 16th 2017While US healthcare providers are growing more willing to adopt lower-cost biosimilar drugs as way to address the rising costs of biologic treatment, biosimilar developers are facing yet another challenge: competing against reference products for a preferred place on formularies.
ABP 980 Exhibits Comparable Safety and PK Profile to Reference Trastuzumab
August 16th 2017A phase 1 trial of ABP 980, Amgen’s proposed biosimilar of reference trastuzumab (Herceptin), demonstrated ABP 980’s pharmacokinetic similarity to both US-approved reference trastuzumab and European Union-approved reference trastuzumab. Amgen and Allergan have submitted applications for approval of ABP 980 with both the FDA and the European Medicines Agency.
Budget Impact Analysis Shows a Need for Deep Discounts for Biosimilar Infliximab
August 16th 2017Although the use biosimilar infliximab in rheumatoid diseases and inflammatory bowel disease has the potential to reduce the treatment costs, a variety of factors may influence the adoption of biosimilar treatments and their potential impacts on healthcare budgets.
EMA Scales Back Activities, Prioritizes Tasks to Cope With Brexit
August 15th 2017The European Medicines Agency announced this month that it has initiated a business continuity plan to cope with the political uncertainty and the workload implications of the United Kingdom’s impending withdrawal from the European Union.
Study Finds Biosimilar Infliximab CT-P13 Effective, Safe in IBD Patients
August 15th 2017A recent Spanish study concludes that CT-P13, a biosimilar of reference infliximab that has been approved in Korea, the European Union, and the United States, is efficacious and well tolerated in patients with moderate to severe Crohn’s disease (CD) or ulcerative colitis (UC).
Ireland Seeks to Overhaul Biosimilar Drugs Policy
August 14th 2017Ireland’s Minister for Health has published a consultation paper on overhauling the nation’s approach to biosimilar medicines. The paper indicates that the Irish government is developing a National Biosimilar Medicines Policy “to promote the rational use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland.”
Roche Withdraws SLP Against Biocon and Mylan's Trastuzumab Biosimilar
August 14th 2017Roche has withdrawn its Special Leave Petition (SLP) filed in India’s Supreme Court against a March 3 High Court decision to allow Biocon and Mylan to use the Swiss drug maker’s product data for their trastuzumab biosimilar.
Clinical and Cost Effectiveness in Switching From Innovator to Biosimilar Infliximab
August 12th 2017The Canadian Agency for Drugs and Technologies in Health reviewed the clinical effectiveness, cost-effectiveness, and advice from guidelines concerning switching from innovator to biosimilar infliximab for the treatment of several autoimmune diseases: rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, ulcerative colitis, and psoriatic arthritis.
ACA Uncertainty Gives Rise to Stark 2018 Premium Changes
August 11th 2017Insurers operating in the Affordable Care Act marketplace face fresh uncertainties as they plan for 2018: whether Congress will continue in its efforts to repeal or replace the ACA, whether the Trump administration will enforce the individual mandate, or even whether the federal government will continue to pay insurers for cost-sharing reductions are all unanswered questions.
TARGET Trial: Sarilumab Improves PROs in Rheumatoid Arthritis
August 10th 2017A recently published study demonstrates that sarilumab improves patient-reported outcomes in patients with rheumatoid arthritis who did not achieve adequate response with, or who were intolerant to, anti-tumor necrosis factor (anti-TNF) agents.