NICE: Pertuzumab Not Cost-Effective, Even When Used With Biosimilar Trastuzumab
August 20th 2018The National Institute for Health and Care Excellence (NICE) evidence reviewers considered a biosimilar discount of 70% to 90% off the reference trastuzumab’s price at a 90% to a 100% market share, and the Cancer Drugs Fund provided the committee with confidential information on the weighted average price and market share for available biosimilar trastuzumab products.
Eye on Pharma: JHL Biotech to Begin Phase 3 Trial of Biosimilar Trastuzumab
August 18th 2018This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted the company positive scientific advice to begin a phase 3 clinical trial of its proposed trastuzumab biosimilar, JHL1188.
Rheumatology and Oncology Providers Voice Concern Over CMS Step Therapy Plan
August 17th 2018Although the policy change was intended to cut out-of-pocket drug costs for patients, a number of organizations, including the American College of Rheumatology (ACR), have argued that step therapy can be harmful to patients with chronic conditions. On Wednesday, ACR met with HHS Secretary Alex Azar to discuss their concerns.
Eye on Pharma: Bracing for Biosimilars, Genentech Will Lay Off 223 Employees
August 16th 2018As biosimilar competition nears for Roche and its subsidiary, Genentech, a new WARN notice in the state of California disclosed that Genentech is set to lay off 223 employees from a local plant beginning August 31, 2018.
California Lawmaker Says Insulin Maker Is in "Egregious Defiance" of Drug Pricing Law
August 16th 2018Eli Lilly says that it will not comply with a 2017 California law on drug pricing, and now the state senator who sponsored the bill is hitting back against the drug manufacturer, calling the company’s activities to promote its diabetes programs “disingenuous and offensive.”
Treating RA With Infliximab, Adalimumab, or Golimumab May Allow for Later Biologic-Free Remission
August 16th 2018In analyzing the association between biologic-free remission maintenance and the type of biologic drugs that patients had used, a notable difference emerged between patients who used infliximab, adalimumab, or golimumab versus those who received etanercept and certolizumab pegol.
Irish HTA Official Calls for All New Patients to Start With Biosimilars
August 15th 2018Clinical director of the Irish health technology assessment (HTA) body National Centre for Pharmacoeconomics (NCP), Michael Barry, MB, FRCPI, PhD, recently said in an interview with Irish media that the lack of uptake of biosimilars in Ireland is “an issue that should be tackled,” and he proposed approaches to do just that.
Study: Switching to SB5 From Humira Is Safe and Well Tolerated at 1 Year
August 15th 2018Full 52-week results of the study, which included a switch from the reference adalimumab to SB5, demonstrate that the biosimilar was well tolerated and that switching led to no change in treatment-emergent adverse events.
FTC Weighs in on Biosimilar Competition
August 15th 2018In the FDA’s Biosimilar Action Plan, the agency indicated that it seeks to partner more closely with the Federal Trade Commission (FTC) to help remove barriers to competition that are not directly within the FDA’s control. However, in recent comments to HHS, the FTC has called on the FDA to use its own authority to foster biosimilar competition.
Follow-On Insulin Glargine Shows Similar Safety, Efficacy to Lantus in T1D
August 14th 2018While US patients with diabetes await the launch of the follow-on, which is expected to offer a welcome cost-savings, newly published data from a 52-week clinical trial in patients with type 1 diabetes (T1D) underscore its similar safety and efficacy to the reference insulin glargine.
As Adalimumab Biosimilar Competition Heats Up, AbbVie Sues Sandoz
August 13th 2018This month, AbbVie filed suit against biosimilar developer Sandoz over its proposed adalimumab (Humira) biosimilar. The suit was filed in the District of New Jersey and alleges infringement under the Biologics Price Competition and Innovation Act.
Observational Study Confirms Safety Profile of Biosimilar Epoetin Alfa in Nephrology
August 13th 2018While the United States is still awaiting the launch of the first FDA-approved biosimilar epoetin alfa, erythropoiesis-stimulating agents were among the first biosimilars to become available in Europe. This month, Italian researchers published a post-authorization observational study that compared the efficacy and safety of 2 European biosimilars and the reference epoetin alfa in patients undergoing dialysis at 26 hospitals in 4 regions in Italy, and they concluded that their results support the comparable safety profiles of the originator and biosimilar products.
Patient-Administered Biosimilar and Follow-On Filgrastim Pose Opportunity for Savings
August 13th 2018Studies have demonstrated that using follow-on and biosimilar granulocyte colony-stimulating factor (G-CSF) agents can produce cost savings and expand patient access to prophylaxis of febrile neutropenia. Now, a newly published budget impact analysis finds that even greater savings may be possible if patients self-administer these agents at home rather than visiting a provider to receive an injection.
Review Documents 15 Years of Experience With Adalimumab in Psoriasis
August 12th 2018This Psoriasis Awareness Month, a new review of real-world experience with adalimumab (Humira) in patients with psoriasis finds that adalimumab is slightly less safe, but has better effectiveness and drug survival, than other biologic treatment options.
Bevacizumab Biosimilar, CT-P16, Ready for Phase 3 Trial
August 10th 2018Celltrion has announced that it is ready to begin a phase 3 trial of its proposed bevacizumab biosimilar, CT-P16. The multicenter study will begin in Portugal and will eventually include approximately 150 sites in 20 nations in Europe, Asia, and South America.
CMS Says Its Step Therapy Plan May See More Patients Using Biosimilars
August 9th 2018CMS this week announced a policy that will allow Medicare Advantage (MA) plans to negotiate drug prices for physician-administered and other Part B drugs by allowing plans to employ the utilization management strategy known as step therapy to newly diagnosed patients.
Tbo-Filgrastim Gains a New Pediatric Indication and Vial Presentation
August 9th 2018Teva announced this week that the FDA has approved its tbo-filgrastim (Granix), a follow-on product referencing Neupogen, to reduce the duration of severe neutropenia in patients as young as 1 month old who have nonmyeloid malignancies and are receiving myelosuppressive chemotherapy.
Express Scripts Says Its Formulary "Exposes Opportunities" to Improve Affordability
August 8th 2018Express Scripts framed its formulary as a response to pharma: “Despite promises to limit price increases, drug makers are trying to game the market by delaying generic competition, blocking access to safe and effective biosimilars, and coyly deferring—not cancelling—list price increases,” it said.
United Kingdom Proposes Applying Price Controls to Biosimilars
August 8th 2018The government has launched a consultation that outlines the proposed changes to its price controls, which require brand-name drug makers to pay the government 7.8% of their sales of products to the National Health Service.
Celltrion Announces Simultaneous Phase 1, Phase 3 Trials for Adalimumab Biosimilar
August 8th 2018Korean drug maker Celltrion has announced that it ready to begin phase 1 and phase 3 clinical trials for CT-P17, a proposed adalimumab biosimilar referencing AbbVie’s Humira, which is used to treat a variety inflammatory diseases. The trials will be conducted simultaneously at 75 sites in 8 nations in the European region including the United Kingdom, and the company indicates that the trials will be completed by 2020.