Biosimilars Make Progress in the Canadian Market, but Stakeholders See More Work Ahead
November 18th 2019While much attention over the past few weeks has been on the US biosimilars market, with its recent approvals and product launches, Canada has also been making strides in its own biosimilars experience.
Anti-VEGFs May Provide Substantial Economic Value to Patients and Society in Treating Wet AMD
November 18th 2019The field of biosimilar contenders for anti–vascular endothelial growth factor (anti-VEGF) therapies is taking shape, with biosimilar developer Coherus seeking to launch its ranibizumab biosimilar in 2021 and Samsung Bioepis having reached a commercialization agreement for 2 biosimilar anti-VEGFs of its own. Last week, a study published in JAMA Ophthalmology supported the use of anti-VEGF agents in wet age-related macular degeneration (AMD), saying that, though these drugs are costly, they may provide substantial economic value to both patients and society.
Novartis Confirms It Has Launched Biosimilar Pegfilgrastim, Ziextenzo, in the United States
November 15th 2019Novartis has confirmed in an email to The Center for Biosimilars® that it has launched Sandoz’s pegfilgrastim biosimilar, Ziextenzo, in the United States. According to Novartis, the wholesale acquisition cost (WAC) for Ziextenzo is $3925, or an approximate 37% discount off the WAC for the reference product, Amgen’s Neulasta.
AARP Says Brand-Name Drug Prices Outpaced Inflation Once Again in 2018
November 15th 2019The AARP Public Policy Institute has released a new Rx Price Watch report showing that, last year, the retail prices of 267 brand-name drugs that are commonly used by older Americans rose by an average of 5.8%—more than twice the general rate of inflation, which was 2.4%.
Bill to Stop Disingenuous Citizen Petitions Advances in House
November 15th 2019A House subcommittee voted unanimously Thursday to send a bill intended to stop sham citizen petitions from clogging the FDA’s approval process for generic drugs under the section 505 pathway to the full Energy and Commerce Committee.
WHO Launches Pilot Prequalification for Human Insulin
November 14th 2019The World Health Organization (WHO) this week announced its pilot procedure for the prequalification of human insulin as means to facilitate access to safe, effective, and quality-assured insulin and insulin biosimilars for type 1 and type 2 diabetes in low- and middle-income countries.
Designing Today's Policies for Tomorrow's EU Biosimilar Portfolios
November 11th 2019Today in the European Union, we can be proud and celebrate the fact that in 28 EU Member States, biosimilar medicines are in use, and competition in the biological medicines field has consistently brought value for patients and healthcare communities. In general, broader access (more patients treated) is an immediate consequence of biosimilar competition, and earlier access to treatment (where clinically appropriate) has been observed in a number of countries.
Employers Call on Congress to Take Action on Drug Prices as the Cost of Providing Coverage Grows
November 8th 2019The high cost of healthcare is putting a strain on employers who provide health insurance coverage to their employees, and prescription drug prices are now front and center in the push to make coverage more affordable to provide to American workers.
Orphan Biosimilars: an Untapped Opportunity?
November 8th 2019Biosimilars have made headlines for their potential to offer a more affordable treatment option to patients in need of biologics. Today, with the increasing knowledge and identification of rare diseases, biosimilars have a renewed purpose in healthcare; they represent a significant opportunity to fulfill the unmet medical needs of rare disease patients at a much lower cost.
First Rituximab Biosimilar, Truxima, Launches in the United States
November 7th 2019Teva and Celltrion have announced the launch of their biosimilar rituximab, Truxima, in the United States. The product is being offered at a 10% discount to the list price of reference product, Rituxan. The product will begin to reach patients on November 11.
Biocon Receives EIR, Says It Plans to Launch Biosimilar Trastuzumab, Ogivri, in the US "Soon"
November 6th 2019The FDA has issued an establishment inspection report (EIR) for Biocon’s Bengaluru facility, where the drug maker manufactures biosimilars, and the FDA’s inspection of the facility, which took place during August 2019, is now closed.
FDA Approves Sandoz's Pegfilgrastim Biosimilar, Ziextenzo
November 5th 2019The FDA has approved Ziextenzo (pegfilgrastim-bmez), Sandoz’s biosimilar pegfilgrastim referencing Neulasta. The biosimilar was approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive anticancer treatment. Sandoz plans to launch the product this year.
UnitedHealthcare Patients Will Switch to Biosimilar Epoetin Alfa in 2020
November 4th 2019UnitedHealthcare has revised its community and commercial plans’ coverage of erythropoiesis-stimulating agents. Effective January 1, 2020, patients who are receiving the reference epoetin alfa, Epogen or Procrit, will be required to switch to Pfizer’s biosimilar, Retacrit.
Research Letter Suggests That Off-label Use May Be Boosting Eculizumab Sales
November 2nd 2019In a research letter appearing this week in JAMA Internal Medicine, authors from Oregon Health and Science University raised the question of whether the “large and increasing revenue from eculizumab” could be tied to off-label use for non-approved indications.
Novartis' Secukinumab Narrowly Misses End Point in Trial Against Adalimumab
November 1st 2019Novartis Friday announced results from a head-to-head trial of its secukinumab (Cosentyx) versus adalimumab in patients with active psoriatic arthritis (PsA), saying its therapy missed statistical significance for its primary end point.
AbbVie's International Humira Revenues Drop 33.5% After Biosimilar Competition
November 1st 2019In its third quarter 2019 financial results, AbbVie, maker of the blockbuster Humira, said that its international revenues for the brand-name adalimumab were $1.049 billion, or a decrease of 33.5% on a reported basis, after having faced competition from biosimilars.