HSGAC Report: Drug Prices Rise at 10 Times the Rate of Inflation
April 2nd 2018Last week, Senator Claire McCaskill, D-Missouri, together with the minority staff of the Senate Homeland Security and Government Affairs Committee (HSGAC), released a report on prescription drug price increases that affect the 20 products most commonly prescribed to seniors.
Eye on Pharma: Pfenex May Resume Biosimilar Development on Ranibizumab and Pegfilgrastim
April 1st 2018In Pfenex’s fourth-quarter 2017 investor call, Evert Schimmelpennink, CEO, president, secretary, and director, hinted that Pfenex may be ready to resume work on 2 biosimilar candidates whose programs had been on hiatus.
Theradiag Partners with Biogaran on Infliximab Biosimilar Monitoring Kits in France
March 31st 2018Last week, Theradiag, a French company specializing in in vitro diagnostics and theranostics (targeted therapy based on findings in diagnostic tests) announced that it has entered a new partnership agreement with pharmaceutical group Biogaran.
Mergers, Acquisitions, and Rebates: The Latest Healthcare Shakeups
March 30th 2018Walmart is reportedly in early talks with Humana; Aetna says that it will automatically apply pharmacy rebates at the time of drug sales for its fully insured commercial plan members; and the American Antitrust Institute is raising concerns about 2 proposed acquisitions.
As Biosimilar Competition Nears for Pegfilgrastim, a Novel Long-Acting G-CSF Agent Shows Promise
March 29th 2018Eflapegrastim is novel long-acting granulocyte-colony stimulating factor therapy. Pharmacokinetic analysis in vivo demonstrated a 2- to 3-fold increase in area under the time‐concentration curve for absolute neutrophil count versus pegfilgrastim when administered at similar doses, and the proposed drug demonstrated comparable efficacy compared with pegfilgrastim in an open-label study in patients with breast cancer who were receiving docetaxel and cyclophosphamide.
FDA Fears USP's Monograph Changes Could Discourage Biosimilars
March 29th 2018One of the more serious concerns the FDA has discussed is the possibility that a developer of a proposed biosimilar could be deterred from seeking approval of its product, because United States Pharmacopeial Convention's (USP) proposed changes could complicate the licensure of a proposed biosimilar that meets the approval requirements of the FDA but does not match the USP’s standards of a monograph.
Gottlieb: FDA Working on "A Dozen Policies" on Biosimilars
March 29th 2018FDA Commissioner Scott Gottlieb, MD, indicated that the agency would be putting forward policies that would compel branded drug makers to “tighten up their manufacturing, to have less variance of their biologics that are currently on the market.” In theory, this change could make it easier to develop a biosimilar using smaller studies.
Anti-VEGF Drugs Not Associated With Increased Risk of AEs in Eye Diseases
March 28th 2018Last week, an overview of systematic reviews and meta-analyses investigating systemic adverse events associated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatments was published in JAMA Ophthalmology.
Without Policy Changes, a Stable Biosimilars Market "May Not Flourish"
March 28th 2018A new brief from Avalere Health argues that, if a multisource market for biologic drugs is to emerge in the United States, originator biologics and biosimilars must be able to gain market share commensurate to the value they offer to the healthcare system, and a variety of policy options are available to create the necessary conditions for true competition.
Mylan and Biocon's Biosimilar Insulin Glargine Authorized in European Union and Australia
March 28th 2018The biosimilar insulin will be sold under the brand name Semglee in a 100 IU/mL 3mL prefilled pen presentation in both territories. Mylan and Biocon say that they plans to launch the product in various markets in Europe in the second half of 2018, and in Australia “later this year.”
European Council Hints That United Kingdom Will Be Excluded from EMA
March 27th 2018UK Prime Minister Theresa May has called for the United Kingdom to remain a member of the European Medicines Agency (EMA), but the European Council says that "The Union will preserve its autonomy as regards its decision-making, which excludes participation of the United Kingdom as a third-country to EU Institutions."
Recognition Is Nice, But Accuracy Is Most Important When It Comes to Biosimilars
March 27th 2018If the commentary we offer to improve the poor comprehension about biosimilars itself contains errors or a limited appreciation of the approval framework, the task of creating a stable and competitive market to reduce pharmaceutical expenses becomes that much more difficult.
Policy Barriers Limit Biosimilar Access in Some European Nations
March 27th 2018While biosimilars have made significant inroads into the European marketplace, there remain hurdles to the adoption of these lower-cost drugs, especially in lower-income nations; external reference pricing can mean that drugs are priced to wealthier European countries’ financial capabilities, and manufacturers’ launch strategies may bring biosimilars to nations with the greatest market potential first.
Study: Rituximab Associated With More AEs Than Other Infusions in Pediatric Patients
March 26th 2018Intravenous infusion therapy has become critical for the treatment and maintenance of many pediatric rheumatic diseases, such as juvenile idiopathic arthritis, systemic lupus erythematosus, and inflammatory bowel disease-associated arthritis. Recently, researchers conducted a retrospective review of all pediatric patients given infusions at the University of Alabama at Birmingham from 2012 to 2015.
Oncologists Address the Role of Biosimilars in Cancer Care at NCCN Annual Conference
March 26th 2018During a symposium held during the 23rd annual conference of the National Comprehensive Cancer Network (NCCN), held last week in Orlando, Florida, Andrew D. Zelenetz, MD, PhD, of Memorial Sloan Kettering Cancer Center; Jeffrey Crawford, MD, of Duke University; and Lee Schwartzberg, MD, FACP, of University of Tennessee Health Science Center, presented on the use of biosimilars in oncology.
European Competition for Trastuzumab to Heat Up as ABP 980 Gains Positive CHMP Opinion
March 25th 2018Amgen and its partner Allergan announced Friday that their ABP 980, a trastuzumab biosimilar referencing Herceptin, has gained a positive opinion for marketing from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
Trump Promises "Major" News on Drug Pricing "In About a Month"
March 24th 2018Earlier this week, President Donald Trump made a speech in New Hampshire to discuss the administration’s efforts in combatting both the opioid crisis and high drug prices. In the speech, Trump alluded to a possible press conference in the near future that would discuss potential proposals in reducing prescription drug prices.
CHMP Grants Sandoz Positive Opinion for Proposed Infliximab Biosimilar
March 23rd 2018Novartis division Sandoz announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for the marketing authorization of biosimilar infliximab.
Rituximab Induction Is Cost Effective for Asymptomatic Advanced Follicular Lymphoma
March 23rd 2018Rituximab induction therapy has the highest probability of cost effectiveness in treating newly diagnosed patients with asymptomatic advanced follicular lymphoma, according to a study published in the British Journal of Haematology.
AHIP's New CEO Supports Reducing Drug Costs Through Robust Biosimilar Market
March 22nd 2018Insurance lobbying group, America’s Health Insurance Plans (AHIP), recently named Matt Eyles as its next president and CEO beginning June 1. Eyles, currently AHIP’s chief operating officer, recently gave a statement about his priorities for the organization once he begins his tenure.