Biosimilars

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.

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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.

The first oncology therapeutic biosimilars are now available in the United States.

Amgen’s ABP 501 (Amjevita) shows similar efficacy to the reference adalimumab (Humira) in treating rheumatoid arthritis and supported approval of the biosimilar by the FDA.

Lawsuit alleges that patients paid artificially high prices for brand-name Humira, and that they were deprived of the benefits of early, robust competition from biosimilars as a result of wrongful conduct.

Rituximab is approved by the FDA for the treatment of adults with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

Biosimilars present a cost-saving opportunity for the health care system, but significant challenges inhibit uptake in the US market.

As biosimilar development continues to grow, pharmacists will be essential in transitioning both clinicians and patients alike in the use of these therapies.

At the 2018 ASHP Midyear Clinical Meeting and Exhibition, Ashley Mains Espinosa, PharmD, Director of System Pharmacy Business Services at SCL Health, offered advice on how pharmacy providers can work to overcome biosimilar reimbursement challenges and encourage biosimilar adoption.

Biosimilars adalimumab and etanercept showed equivalent safety and efficacy to reference products in patients with rheumatoid arthritis.

Several hurdles remain for biosimilars to flourish in the US market.

Presenters delved into the topic of biological drugs and gene therapy during the recent International Pharmaceutical Federation (FIP) World Congress in Glasgow Scotland.

Achilles Alon, PharmD, RPh, director of Specialty Pharmacy, co-owner of ACE-Rx Specialty Pharmacy, discusses biosimilars and the potential impact on patient care.

Based on 2017 FDA research, the delayed market launch of nine biosimilars represented $4.5 billion in potential savings.