May 14th 2024
The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
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.
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.
Oregon Enacts Law to Demand Transparency in Drug Pricing
March 17th 2018House Bill 4005 requires drug manufacturers to compile a report on a prescription drug if the price was $100 or more for a 1-month supply (or course of treatment lasting less than 1 month) and if the net price increased by 10% or more.
CEO of Michigan Pharmacists Association Reacts to New Law on Biosimilars
March 11th 2018"The pharmacist remains a very important member of the healthcare team that has the ability to explain to the patient the differences between the biologic and the biosimilar. It is the pharmacist–patient relationship that will assist the patient in making the best decisions to obtain the optimal clinical outcome," said Larry D. Wagenknecht, PharmD, FMPA, FAPhA, CEO of the Michigan Pharmacists Association.
Senators Introduce Legislation to Limit Sovereign Immunity From Patent Challenges
March 10th 2018This week, Senators Tom Cotton, R-Arkansas, and Claire McCaskill, D-Missouri introduced the Preserving Access to Cost-Effective Drugs (PACED) Act in response to Allergan’s recent transfer of its patents covering its dry-eye drug, Restasis, to the Saint Regis Mohawk Tribe in exchange for the Tribe’s invocation of sovereign immunity against inter partes review.
Canadian Health Plan to Switch Patients to Biosimilar Etanercept and Infliximab
March 8th 2018Green Shield Canada (GSC), a not-for-profit health benefits company that offers employee group health benefits that supplement government-sponsored provincial health plans, has announced a new program to switch patients to biosimilar therapies.
We Do Not Need to Reinvent the Wheel on Biosimilar Safety, Says Avalere's Gillian Woollett
March 7th 2018Gillian Woollett, MA, DPhil, senior vice president of Avalere and leader of the company’s FDA practice, told The Center for Biosimilars® in an interview that a study she co-authored is aimed at reassuring all biosimilar stakeholders that, “even though no clinical differences are expected when patients are switched from a reference product to a biosimilar, indeed none are found. Hence, we confirm the expectation already established through the application of sound regulatory science.”
Michigan Governor Signs Legislation Allowing Biosimilar Substitution
March 6th 2018The law, which was passed with broad bipartisan support in both the Michigan House and Senate, allows for biologics designated by the FDA as interchangeable to be substituted at pharmacies with appropriate communication of the substitution to both patients and physicians.
Canadian Agency for Drugs and Technologies in Health Revises Biosimilar Submission Procedures
March 2nd 2018The Canadian Agency for Drugs and Technologies in Health, the Canadian entity responsible for health technology assessments, has announced that it has revised its approach to reviewing biosimilars.
Health Economist Warns That Biosimilar Savings Could Be "Left on the Table"
March 1st 2018Richard G. Frank, PhD, a health economist at Harvard Medical School and the former deputy assistant secretary for planning and evaluation at HHS, has penned a new perspective paper in the New England Journal of Medicine in which he warns that, if biosimilars continue their trajectory, they could fail to deliver on their promise to provide cost savings to the US health system.
PhRMA Report: Value-Based Contracts Could Reduce Drug Costs
February 26th 2018Over the past 2 years, commercially insured patients enrolled in plans that had value-based contracts for certain high-cost drugs had lower copays for their medications than did patients enrolled in plans without such contracts. That finding comes from “Delivering Results for Patients: The Value of Value-Based Contracts,” a new report from the Pharmaceutical Research and Manufacturers of America (PhRMA).
PTAB Denies Tribe's Request for Sovereign Immunity From IPRs on Restasis Patents
February 26th 2018The US Patent Trial and Appeal Board (PTAB) has decided that the Saint Regis Mohawk Tribe cannot claim sovereign immunity from inter partes review (IPR) of Allergan’s patents covering Restasis, and that the IPR proceedings on those patents can continue with Allergan as the patent owner.
PBSA Asks FDA to Change Biosimilars Materials, But Other Patient Groups Cry Foul
February 21st 2018The Patients for Biologics Safety and Access (PBSA) is calling on the FDA to revise its prescriber-directed online educational materials on biosimilars. However, not all patient groups agree with PBSA’s stance.
AAM White Paper Highlights Need for Biosimilar Competition to Bring Down Costs
February 20th 2018A white paper released this month by the Association for Accessible Medicines (AAM) says that brand-name drugs are behind high prescription drug costs, and that those costs aren’t only hurting patients’ financial wellbeing, but also endangering their health.
Ireland Seeks to Join European Drug Price Negotiation Bloc
February 15th 2018Ireland’s Minister for Health, Simon Harris, announced this week that Ireland is seeking to join Belgium, the Netherlands, Luxembourg, and Austria in their BeNeLuxA Initiative, a group that negotiates price deals on pharmaceuticals directly with manufacturers.
Rheumatologist Sees Gray Areas in ACR White Paper on Biosimilars
February 14th 2018According to Roy Fleischmann, MD, a recent American College of Rheumatology (ACR) white paper appropriately describes issues including the nomenclature of biosimilars, the biosimilar approval pathway, and differences between biosimilars for biologic drugs and generics for small-molecule drugs. However, he takes issue with ACR's stance on substitution, extrapolation, and interchangeability.
Is the White House Budget at Odds With NIH's Contributions to New Drugs?
February 13th 2018Yesterday, President Trump released his budget proposal for the 2019 fiscal year. On the same day, the Proceedings of the National Academy of Sciences of the United States of America released a paper summarizing the NIH’s contribution of funding to new drugs approved from 2010 to 2016.