Biosimilars

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.

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.

With drugs that achieve similar clinical outcomes, it will ultimately come down to financial differentiation that can determine which drugs lead the market.

Biosimilars are a potential solution to the ever-growing problem of high specialty drug costs.

Top news of the week from Specialty Pharmacy Times.

New policies that aim to help generic drug makers move their products through the development and approval processes more efficiently have been announced by FDA Commissioner Scott Gottlieb, MD.

A new 5-part video series released by the FDA is part of a larger education and outreach effort about biosimilars and interchangeable products.

Top news of the week from Specialty Pharmacy Times.

Retacrit gains FDA approval as a biosimilar to Epogen/Procrit for the treatment of anemia caused by chronic kidney disease, chemotherapy, or in patients with HIV.