Biosimilars

This week on Pharmacy Times, there are a number of important topics that will be covered and posted throughout the week.

The pipeline for biosimilar products in the United States includes at least 26 candidates in phase 3 trials for 13 reference therapies.

Bhavesh Shah, RPh, BCOP; Brandon Dyson, PharmD, BCOP, BCPS; Ryan Haumschild, PharmD, MS, MBA; and Tim Peterson, PharmD, BCOP, provide advice and strategies for adopting biosimilars into clinical practice.

The impact of the COVID-19 pandemic on the rate of biosimilar adoption in clinical practice, updates to NCCN guideline recommendations, and financial implications associated with the utilization of biosimilars.

The influence of provider buy-in for getting a biosimilar onto formulary and the role of providers in the incorporation of biosimilars are discussed.

Overcoming barriers for payer coverage of biosimilars as well as considerations for carrying costs are discussed.

Brandon Dyson, PharmD, BCOP, BCPS, shares his approach to switching a patient already on biologic therapy to a biosimilar, and panelists discuss the importance of education regarding the extrapolation of indications for biosimilars.

A discussion on the extrapolation of European data to aid in P&T (Pharmacy and Therapeutics) committee decisions to adopt the use of biosimilars.

Experts discuss managing biosimilar adoption in various clinical practice settings, working through the P&T (Pharmacy and Therapeutics) approval process, and the importance of relying on a shared-decision making framework.

Ryan Haumschild, PharmD, MS, MBA, provides insight on biosimilar adoption both in oncology and non-oncology practice settings.

The impact on biosimilar utilization in clinical practice caused by secondary patents of biologics and skinny labels of biosimilars is discussed.

Tim Peterson, PharmD, BCOP, leads the discussion on immunogenicity testing and lot-to-lot variability, including the potential impact on the safety and efficacy of reference biologics and their biosimilars.

A discussion on what it means for a biosimilar to have “interchangeability” status and its potential impact on biosimilar adoption in clinical practice.

Ryan Haumschild, PharmD, MS, MBA, defines biosimilars in oncology and what distinguishes them from a reference biologic.

Pharmacy Times® interviewed Chad Landmon, JD, of Axinn, Veltrop & Harkrider, on the arguments presented to the Supreme Court on whether a legislative change to the Affordable Care Act makes the law unconstitutional.

Institutions are replacing innovator biologics with their biosimilars, often to take advantage of the financial benefits.

Study findings align with recent recommendations from the National Comprehensive Cancer Network for preventing febrile neutropenia in patients with early-stage breast cancer.

Cancer care providers have increasingly been using biosimilars on a case-by-case basis with patients.

Cancer medications contribute substantially to the cost of health care in the United States, with 8 of the 10 most expensive drugs indicated for the treatment of cancer

Mylan plans to launch adalimumab-fkjp in the United States in July 2023.

FDA officials based their approval on the review of data and evidence that demonstrated a close similarity between pegfilgrastim-apgf and its reference product.

The FDA does not usually require animalstudies for biosimilars; therefore, the process can move directly to pharmacokinetic and pharmacodynamic studies.

A session on the use of biosimilars, a topic that many pharmacists identify to be of growing importance in their practices, concluded the 2019 Directions in Oncology Pharmacy conference.

Pfizer will become the first to launch 3 oncology monoclonal antibody biosimilar treatments to the US market.

Biosimilars, which at the most simplistic level can be thought of as a type of generic option for a biologic, offer an opportunity to help reduce total biologic drug spend.

Trastuzumab-dkst (Ogivri, Mylan, Biocon), a biosimilar to trastuzumab (Herceptin, Genentech Inc.), has been launched in the US, according to an announcement from Mylan N.V. and Biocon Ltd. It is the first biosimilar approved by the FDA and recommended by the FDA Oncologic Drugs Advisory Committee.

Officials with the FDA have approved adalimumab-afzb (Abrilada, Pfizer), a biosimilar to Humira, for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.

Top news of the day from across the health care landscape

Ron Lanton III, Esq., discusses the specialty pharmacist's role in educating patients about biosimilars and biologics.

Ron Lanton III, Esq., discusses challenges in launching biosimilars after they've been approved.