March 16th 2023
In an article published in Frontiers in Pharmacy, researchers made recommendations to improve the biosimilar regulatory system and refine biosimilar guidelines in China.
Dr Ivo Abraham Column: The 2022 WHO Biosimilar Guidelines—Loosening the Reins or Changing the Track? Part 2March 7th 2023
In part 2 of this 2-part series, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, continued to examine guidelines from the World Health Organization (WHO) and how they view interchangeability and animal study requirements.
Lilly Plans to Launch Insulin Biosimilar at 78% Discount to LantusMarch 2nd 2023
As 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).
Dr Ivo Abraham Column: The 2022 WHO Biosimilar Guidelines—Loosening the Reins or Changing the Track? Part 1February 28th 2023
Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, details how biosimilar guidelines from the World Health Organization (WHO) have changed over time and whether those changes are beneficial for biosimilars in part 1 of this 2-part series.
ACR Supports Affordable Treatments, Use of Biosimilars Following Rigorous Approval ProcessFebruary 27th 2023
The 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 CRLsFebruary 27th 2023
Although 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.
Access 2023: FDA’s Dr Jacqueline Corrigan-Curay Gives Updates on Biosimilar, Generic User Fee ProgramsFebruary 22nd 2023
Jacqueline Corrigan-Curay, MD, JD, principal deputy center director of the FDA's Center for Drug Evaluation and Research, gave a keynote presentation at Access 2023 on how the Biosimilar User Fee Act and the Generic Drug User Fee Act have developed over the last year.
IGBA Panelists Discuss the Global Reputation of Biosimilars, GenericsFebruary 21st 2023
Panelists 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 MarketFebruary 20th 2023
In 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, BiopharmaFebruary 19th 2023
COVID-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.
How Can Employers Be Ready for the Biosimilar Influx?February 17th 2023
Alex Jung and Kim Dwyer, both members of the Midwest Business Group on Health (MBGH) board of directors, discuss why employers should be ready for the explosion of biosimilars entering the market, and how they can prepare.
Access 2023: Panelists Weigh In on the Many Factors Influencing Biosimilar Uptake PatternsFebruary 16th 2023
Two 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 BiosimilarsFebruary 13th 2023
Sarfaraz 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 ChallengesFebruary 7th 2023
Geoff 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 DenmarkFebruary 4th 2023
A 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 RoadmapFebruary 2nd 2023
The 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.
BioRationality: A Dr Sarfaraz Niazi Column—FDA Discloses Changes to Drug Review Process, Biosimilar LicensingJanuary 30th 2023
Sarfaraz K. Niazi, PhD, explains the FDA's changes to the drug review process, the significance of each change, and the published pieces of work that helped inform the FDA's decisions.
Global Use of Medicines Report Predicts Biosimilars Will Save $290 Billion by 2027January 25th 2023
IQVIA’s Global Use of Medicines Report for 2023 has revealed increased uptake of biosimilars around the world and predicted that biosimilars could generate nearly $300 billion in savings by 2027.
IRA Insulin Cap Could Have Saved Medicare Beneficiaries Millions in 2020January 24th 2023
A 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 2023January 24th 2023
Sophia 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 2022January 19th 2023
Patent 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 CountriesJanuary 12th 2023
A 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.
Dr Chelsee Jensen Speaks on How Health Systems Can Build Confidence in BiosimilarsJanuary 8th 2023
Chelsee Jensen, PharmD, pharmaceutical formulary manager at the Mayo Clinic, explains what health organizations and health systems can do to better manage and instill confidence in biosimilars.
BioRationality—A Dr. Sarfaraz Niazi Column: Lessons From 2022 Biosimilar EventsJanuary 4th 2023
Sarfaraz 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.
BioRationality: A Dr Sarfaraz Niazi Column—US Senate Considers Nixing Interchangeability for BiosimilarsDecember 13th 2022
In his newest column, Sarfaraz K. Niazi, PhD, looks into the domestic and international support for removing interchangeability for biosimilars in the United States.
Dr Ivo Abraham Column: 1 Billion People Can Access Biosimilars; What About the Other 7 Billion?November 30th 2022
Now that the world population has reached 8 billion, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, took a look at how high-income countries can increase accessibility to livesaving medicines to the 7 billion people who have limited access to biosimilars.
VOLTAIRE-X Findings in Patients With Chronic Plaque Psoriasis Supported InterchangeabilityNovember 26th 2022
The VOLTAIRE-X randomized controlled trial determined the adalimumab biosimilar BI 695501 (adalimumab-adbm, Cyltezo; Boehringer Ingelheim) met the FDA’s criteria to be designated as interchangeable with the reference product (Humira).
Senator Introduces Bill to Rid Switching Study Requirements for InterchangeabilityNovember 22nd 2022
The Biosimilar Red Tape Elimination Act will seek to increase patient access to biosimilars by reducing switching study requirements for companies to obtain interchangeability designations.