Biosimilars

Requirements will vary based on the nature of the proposed interchangeable product, and may include an evaluation of data and information generated to support a demonstration of a biological product’s biosimilarity.

Biological products will be designated with 4-letter suffixes devoid of meaning.

FDA finalizes guidance for nonproprietary naming of biological products.

Top trends will include changing policies, pursuing value, and improving access to care.

This biosimilar payment model is designed to create a significant financial incentive for physicians to prescribe these drugs.

Alternative payment models for biosimilars and reference products may reduce Part B spending up to 35%.

Novel drug from Pfizer treats moderate to severe rheumatoid arthritis that had an inadequate response to methotrexate monotherapy.

New proposed Humira biosimilar performed well in a clinical trial for rheumatoid arthritis.

Pfizer’s Remicade biosimilar will now be reimbursed by Medicare.

The rule builds on the FDA’s ongoing effort to encourage complete postmarketing safety data on various biologic and device products.

Both combination product applicants and constituent part applicants are required to comply with postmarketing safety reporting rules.

Biosimilar erythropoiesis-stimulating agent epoetin was well-tolerated and efficacious in the treatment of geriatric patients with chemotherapy-induced anemia.

Top articles of 2016 on Specialty Pharmacy Times.

The biosimilar epoetin was well-tolerated in elderly cancer patient populations.

Results from an interim analysis show ritixumab biosimilar to be equivalent to reference product.

Etanercept found equally as effective as Enbrel in treating plaque psoriasis.

Etanercept found equally effective treating plaque psoriasis compared with Enbrel.

Biosimilars can provide an easily accessible, low cost treatment option for patients with rheumatoid arthritis.

Regulatory perspectives presented at ACR on biosimilars entering the market convey the importance of crafting antibodies to our own purposes.

Amgen will present findings from clinical studies of both branded and investigational drugs.

A majority of specialty physicians have knowledge gaps when it comes to biosimilars.

Physicians may lack knowledge about fundamental information regarding biosimilars.

Biosimilars have been in the news quite a bit lately. Here’s an update on some of the big developments related to biosimilar development, approval, and regulations

Inflectra is the first biosimilar monoclonal antibody approved by the FDA.

Top news of the day from across the healthcare landscape.