December 4th 2023
Sarfaraz K. Niazi, PhD, comments on a poll he conducted revealing that many are still hesitant to remove clinical efficacy study requirements for biosimilars in his latest column.
December 2nd 2023
A survey explores the experiences of health care providers (HCP) in New Zealand throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in 2022.
November 28th 2023
Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
November 23rd 2023
The legal and common uses of “interchangeability” continue to be conflated.
November 20th 2023
Sarfaraz K. Niazi, PhD, offers hope for the end of interchangeability labels in the United States in his latest column.
BioRationality: A Dr Sarfaraz Niazi Column—Avoid Delays in Biosimilar Approvals Due to CRLs
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 Programs
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, Generics
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 Market
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, Biopharma
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?
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 Patterns
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 Biosimilars
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 Challenges
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 Denmark
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 Roadmap
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 Licensing
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 2027
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 2020
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 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 2022
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 Countries
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 Biosimilars
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 Events
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.
Ontario Begins Biosimilar Switching Policy
Over 2 years after a cabinet vote to establish a biosimilar switching policy, the Ontario government is putting one in place, making it the seventh province and eighth jurisdiction in Canada to do so.
BioRationality: A Dr Sarfaraz Niazi Column—US Senate Considers Nixing Interchangeability for Biosimilars
In his newest column, Sarfaraz K. Niazi, PhD, looks into the domestic and international support for removing interchangeability for biosimilars in the United States.
ACMA Begins Board Certification Program for Biologics, Biosimilars Specialists
The Accreditation Council for Medical Affairs (ACMA) is launching a new program for health care professionals to become Board Certified Biologics and Biosimilars Specialists.
Dr Ivo Abraham Column: 1 Billion People Can Access Biosimilars; What About the Other 7 Billion?
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 Interchangeability
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).
Rezvoglar Becomes Second Interchangeable Insulin Biosimilar
The FDA has granted Eli Lilly’s long-acting insulin glargine biosimilar, Rezvoglar, an interchangeability designation, making it the second interchangeable insulin biosimilar in the United States.
Senator Introduces Bill to Rid Switching Study Requirements for Interchangeability
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.
Biosimilar Check-in: PBM to Cover Adalimumab Biosimilars; World’s First Denosumab Biosimilar; Organon Launches in Canada
Organon Canada launches 2 biosimilars referencing Avastin (bevacizumab) and Herceptin (trastuzumab), China became the first country to approve a denosumab biosimilar, and Optum Rx, a large pharmacy benefit manager (PBM), said that it will add adalimumab biosimilars to formulary.
Contributor: What Is the Value of the Interchangeability Designation for a Biosimilar?
If every adalimumab biosimilar had an interchangeability designation, the United States could save additional $765 million annually, according to calculations from 3 biosimilar experts.
AAM's Craig Burton: Is the Biden Administration Doing Enough to Help Biosimilars?
Craig Burton, senior vice president of policy and strategic alliances at the Association for Accessible Medicines and executive director of the Biosimilars Council, gives insight into the many health policies that the Biden administration has implemented in 2022 as well as their possible impact on biosimilar adoption.
BioRationality: A Dr Sarfaraz Niazi Column—FDA Launches Biosimilar Regulatory Science Program
Sarfaraz K. Niazi, PhD, dived into the benefits of the FDA's recently announced Biosimilar Regulatory Science Program, which is expected to help progress biosimilar development and simplify evaluations for interchangeability status.
2 Clarke Drive Cranbury, NJ 08512