Biosimilars

The Generic Pharmaceutical Association and its Biosimilars Council are pleased that the Food and Drug Administration (FDA) has issued its draft guidance on biosimilar labeling.

Access to biologics increased by as much as 100% after biosimilars became available.

Biosimilars face scrutiny before they can be indicated for inflammatory bowel diseases, such as Crohn's disease and ulcerative colitis.

Although only 1 biosimilar has been approved in the United States thus far, pharmacists can expect to see a lot more action in this space in the next few years.

Controversy swirls around the naming protocol for biosimilars among drug manufacturers and the FDA.

There are several ongoing global phase 3 clinical trials for biosimilar adalimumab, which treats conditions such as rheumatoid arthritis, psoriatic arthritis, and Crohn's Disease.

A summary of the clinical potential of biosimilar therapies and special considerations for older patients with cancer.

The drug is the first biosimilar monoclonal antibody to be considered by the FDA.

Pharmacists must understand the potential value of biosimilars as a competitive generation of more cost efficient drugs hit the market.

National Association of Specialty Pharmacy (NASP) Executive Director James E. Smeeding, RPh, MBA, discusses the potential of biosimilars to reduce the cost burden of specialty pharmaceuticals.

Submission bolstered by trials evaluating biosimilar candidate in moderate-to-severe plaque psoriasis and rheumatoid arthritis.

An understanding of biosimilars will be essential for patient consults and education.

Treatment helps reduce infection risk from low white blood cell count in cancer patients receiving chemotherapy.

Several states have enacted more stringent laws that still require prescriber notification or authorization prior to dispensing an interchangeable biosimilar.

Office of Generic Drugs will no longer require final printed labeling to approve Abbreviated New Drug Applications.

Tumor necrosis factor alpha inhibitor can also treat autoimmune diseases such as rheumatoid arthritis and psoriasis.

David Lassen, chief clinical officer at Prime Therapeutics, discusses the potential long term impact from biosimilars on the specialty drug landscape.

Doug Long, vice president of industry relations at IMS Health, discusses if health care providers will be hesitant to prescribe biosimilars.

Amy Grogg, PharmD, senior vice president of Strategy and Commercialization at AmerisourceBergen Specialty Group, discusses the projected ramifications from the launch of biosimilars in the United States.

Cancer therapy filgrastim-sndz (Zarxio) was initially approved on March 6, 2015.

Policy may mitigate inaccurate perceptions of safety and efficacy for biological products.

The FDA has proposed adding a 4-letter suffix to the names of biosimilars to distinguish them from their biologic counterparts.

Study estimates United States is wasting $45 million every month that biosimilar Zarxio is not on the market.

Top stories of the week on Specialty Pharmacy Times.

Marc O'Connor, Chief Operating Officer of Curant Health, discusses the potential impact of biosimilars on the specialty drug market.

Michael Zeglinski, Vice President of Specialty Pharmacy Operations at BriovaRx, discusses whether the R&D cost for biosimilars will affect the overall cost reduction.

Pharmacists will need to evaluate several new factors when selecting and dispensing products.

With biosimilars set to enter the US health care market, pharmacists will soon have new factors to consider when selecting and dispensing products.

Top stories of the week on Specialty Pharmacy Times from July 13 to July 17.

Pfizer executive discusses the present and future of biosimilars.