Biosimilars

What are biosimilars? The Pharmacy Times® Biosimilars resource center keeps those in the space up to date with the latest clinical news and articles, coverage from conferences and meetings, links to condition-specific resources, and videos and other content.

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Interchangeability Status in Biosimilars

Defining what it means to have an “interchangeability” designation as it relates to biosimilars and insight on challenges with regulations of holding this status.

FDA Approval Process of Biosimilars

A review of the steps of the FDA approval process for biosimilars and a discussion on immunogenicity and quality assurance for biosimilars.

Comparison of Biosimilars vs Biologic Agents

Clinical pharmacists provide an overview of the similarities and differences of biosimilars vs biologics including a comparison of dosing and storage conditions.

The Evolution of Oncology Biosimilars and the Potential to Improve Patient Access to Biologics

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 Introduces Three New Oncology Biosimilars to US Market

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

Overview of the Biosimilar Landscape

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.

FDA Approves Biosimilar for Multiple Inflammatory Conditions

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

The Specialty Pharmacist's Role in Educating Patients about Biosimilars and Biologics

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

Challenges to Launching Biosimilars

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

First Oncology Biosimilars Launched in United States

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

The Pharmacy Times® Biosimilars condition center provides a source of all the latest clinical information, with articles covering updates from the robust pipeline of biosimilars, and the newest data from all phases of clinical trials and studies.

Among its other resources are a wealth of videos including interviews with thought leaders and experts in biosimilars, and moderated panel discussions about the best practices and key methods for treating complex cases, utilizing the newest biologic medical products replicating medical products originally manufactured by popular companies.