Joseph Markenson, MD
Department of Rheumatology
Department of Medicine
Hospital for Special Surgery, New York, NY
Attending Physician, Hospital for Special Surgery
Professor of Clinical Medicine, Weill Cornell Medical College
Attending Physician, Department of Medicine, Memorial Sloan-Kettering Cancer Center
In general, what kinds of comparable outcomes and end points are investigators documenting for when comparing the reference molecule to a biosimilar agent that is being evaluated for similar disease states?
What can we expect in terms of price reductions for biosimilar vs. the reference product? What factors determine these pricing patterns for biosimilars?
Where does the evidentiary grounding come from to achieve FDA approval for a biosimilar? How many clinical trials are required to support the analytics? What end points are evaluated? Molecularly speaking, how close is the end result likely ...
Can you explain current policy guidance as it relates to biosimilars, including considerations that do or do not apply to “extrapolation,” “substitutability,” and/or “interchangeability” for anti-TNF biosimilars? And what are the product naming guidelines?
How do we educate clinicians and pharmacists to ensure and facilitate appropriate, safe, outcome- and cost-effective deployment of anti-TNF biosimilars in the setting of RA, AS, and related conditions?
How “similar” are biosimilars to the originator product? What confidence intervals are acceptable and what level of analytical rigor and drift are acceptable? What parameters must be synchronized between the originator and biosimilar to ...
The naming of the biosimilars is creating a lot of confusion. Can you give us a roadmap for making sense of the naming strategies for these drugs?
What is the real world data supporting the use of infliximab biosimilars such as INFLIXIMAB-DYYB?
What is the real world data supporting the use of infliximab biosimilars such as INFLIXIMAB-DYYB?
How should clinicians managing patients with RA select among available agents, including biosimilars for infliximab?
What factors fueled the introduction of biosimilars?
How will we make drug selection and sequencing choices now that biosimilars, including ant-TNF agents, are available?
Can you discuss the immunogencity issues —i.e., anti-drug antibodies (ADAs) — for biosimilars vs reference biologics; and how we can apply results of clinical trials comparing biosimilar anti-TNFs to the front lines of drug selection and RA patient care?
What does the landscape for biosimilars look like for RA and other connective tissue disorders look like?
In general, can we extrapolate efficacy of biosimilars across all the disease states for which the originator has indication?
How do we motivate physicians and patients to deploy biosimilars as their go-to therapies?
How do we motivate physicians and patients to deploy biosimilars as their go-to therapies?