May 6th 2024
Sarfaraz K. Niazi, PhD, explains FDA's new guidance on promotional labeling as well as challenges and insights into how this new guidance will impact biosimilars.
Published Data Coupled With Real-world Evidence Show Safety of Biosimilar-to-Biosimilar Switching
March 22nd 2023At the Festival of Biologics, Hillel Cohen, the executive director of scientific affairs at Sandoz, shared the current body of literature on biosimilar-to-biosimilar switching, saying that although there isn’t much published data, the vast real-world experience demonstrates the safety of this type of medication switch.
Uptake Barriers Will Deter Future Competitors From Investing in Biosimilars, Julie Reed Warns
March 21st 2023At the Festival of Biologics, Juliana (Julie) Reed, executive director of the Biosimilars Forum, warned that without changes to encourage biosimilar uptake, companies will begin to ask the big question: Are biosimilars worth investing in?
CVS Predicts Interchangeability Won’t Drive Adalimumab Biosimilar Adoption
March 15th 2023In a report from CVS Health, interchangeability will not be a primary factor in driving the adoption of adalimumab biosimilars referencing Humira, contradicting predictions from other sources that believe the designation will impact prescribing habits.
Biorationality: A Dr Sarfaraz Niazi Column—A New Perspective on Biosimilars' Role Within Big Pharma
March 13th 2023Sarfaraz K. Niazi, PhD, explained why Indian manufacturers aren’t bringing biosimilars to the United States and how FDA policies and procedures discourage global companies from pursuing US market entry.
White Paper Argues Increased Competition Will Improve Biosimilar Uptake, Savings
March 8th 2023A white paper touting biosimilar successes in the United States reasoned that increased market competition will help improve utilization rates, generate substantial savings, and encourage payers to cover biosimilars.
Lilly Plans to Launch Insulin Biosimilar at 78% Discount to Lantus
March 2nd 2023As Eli Lilly and Company announces that it will slash prices for its insulin products and cap out-of-pocket costs for insulin, the company shared that it will launch its interchangeable insulin biosimilar, Rezvoglar, at a 78% discount to the originator (Lantus).
ACR Supports Affordable Treatments, Use of Biosimilars Following Rigorous Approval Process
February 27th 2023The American College of Rheumatology (ACR) steadfastly supports the availability of safe and effective treatments for patients at the lowest cost possible, and underscores the necessity of scientific rigor for biosimilar use and approval.
BioRationality: A Dr Sarfaraz Niazi Column—Avoid Delays in Biosimilar Approvals Due to CRLs
February 27th 2023Although a complete response letter (CRL) is not an official rejection letter, it can result in approval delays by listing out shortcomings in an application and giving companies an opportunity to respond. In his latest column, Sarfaraz K. Niazi, PhD, goes over how companies can avoid these approval postponements.
IGBA Panelists Discuss the Global Reputation of Biosimilars, Generics
February 21st 2023Panelists at the annual meeting of the International Generic and Biosimilar Medicines Association (IGBA) offered insight into the current state of the global biosimilar and generic markets and why government agencies need to leverage these medicines to address challenges in the pharmaceutical space.
Contributor: The Promise of Biosimilars and the Harsh Reality of the US Market
February 20th 2023In theory, by offering a lower-cost treatment option, biosimilars would help drive access for countless patients who simply could not afford the brand-name biologic. However, biosimilars have also encountered the harsh realities of the US health care system and its market forces.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
Access 2023: Panelists Weigh In on the Many Factors Influencing Biosimilar Uptake Patterns
February 16th 2023Two presentations and a panel discussion at the annual meeting of the Association for Accessible Medicines (Access 2023) went over the current state of biosimilar uptake and the factors that help determine whether a biosimilar will experience good adoption rates.
BioRationality: A Dr Sarfaraz Niazi Column—Misconceptions in the Adoption of Biosimilars
February 13th 2023Sarfaraz K. Niazi, PhD, goes over some misconceptions surrounding biosimilar adoption as well as some national efforts to make biosimilar uptake easier and biosimilar development more economically efficient.
Q&A: Patent Attorney Provides Insight Into Biosimilar Legal Challenges
February 7th 2023Geoff Biegler, JD, a principal at Fish & Richardson, an intellectual property law firm, expands on his presentation on biosimilar legal challenges throughout 2022, providing insight on the inner workings of the patent dance and how a Supreme Court decision could have an impact on future cases.
High Treatment Retention Following Biosimilar-to-Biosimilar Switch in Denmark
February 4th 2023A real-world study assessing the aftermath of Denmark implementing a nationwide mandatory switch from one infliximab to another found strong treatment retention rates, demonstrating the safety and tolerability of biosimilar-to-biosimilar switching.
FDA Updates Biosimilar Regulatory Research Program With Roadmap
February 2nd 2023The FDA published its research roadmap as part of the Biosimilars User Fee Act III regulatory research pilot program. The roadmap will allow stakeholders to see how the program will help the FDA enhance regulatory decision-making surrounding biosimilar development.
IRA Insulin Cap Could Have Saved Medicare Beneficiaries Millions in 2020
January 24th 2023A new report from HHS has revealed that if the Inflation Reduction Act (IRA) had been implemented in 2020, Medicare Part D beneficiaries could have saved a total of $734 million, averaging out to about $500 per member.
Contributor: The US Biosimilar Market Outlook for 2023
January 24th 2023Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health in Sacramento, California, details the regulatory decisions from 2022, what's to come in 2023, and how the US biosimilars market is expected to shift over the next 5 years.
Legal Experts Provide Updates on Biosimilar Patent Disputes in 2022
January 19th 2023Patent litigators from Fish & Richardson, an intellectual property law firm, regaled audiences during a webinar covering all the big biosimilar regulatory and legal decisions throughout 2022, including updates on patent disputes and antitrust investigations.
Study Compares Uptake, Prices of Biosimilars in US vs 2 European Countries
January 12th 2023A study assessing uptake rates and prices of biosimilars found that while the United States had significantly higher prices, the uptake in Germany and Switzerland, 2 European countries with national mechanisms for drug price negotiation, was slower.
BioRationality—A Dr. Sarfaraz Niazi Column: Lessons From 2022 Biosimilar Events
January 4th 2023Sarfaraz K. Niazi, PhD, summarizes some of the lessons that the entire biosimilar industry can take away from 2022, including what new legislation and policy changes could mean for future biosimilar development.