Biosimilars

By July 2021, the FDA had approved or tentatively approved 470 generic versions of medications.

Drs Thomas C. Blevins and Diana Isaacs share insight on unmet needs and the future treatment landscape of biosimilars in the treatment of patients with diabetes.

Thomas C. Blevins, MD, ECNU, FACE, FNLA, leads the discussion on potential challenges to the adoption of biosimilars in clinical practice, such as for insulin glargine-yfgn in diabetes management, and discusses the importance of patient and provider education.

Thomas C. Blevins, MD, ECNU, FACE, FNLA, and Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, discuss the impact of interchangeable insulin biosimilars on biologic products in the marketplace for diabetes management.

Prescription drug costs are a significant challenge for Americans, who are paying medication prices higher than any comparable nation.

There is now a mad scramble to gain interchangeable status for biosimilars, but the meaning and significance of this appellation haven't yet been worked out for health care consumers or the manufacturing community.

Women make up to 80% of health care decisions in the United States, but for some, biosimilar knowledge is lacking.

Omalizumab (Xolair) is the oldest available biologic for asthma and is anti–IgE. Mepolizumab, an anti–IL-5 biologic, has been shown to reduce exacerbations and eosinophils and result in improved markers of control.

Pharmacists can play an important role in managing patients on biosimilars and increasing uptake of these products.

The FDA has granted approval of the first interchangeable biosimilar insulin product, insulin glargine-yfgn (Semglee; Mylan Pharmaceuticals), for diabetes.

High-dose buprenorphine therapy, provided under emergency department care, is safe and well-tolerated in patients with opioid use disorder, according to study results.

A community oncology practice implemented a team-based approach to utilizing biosimilars.

The new model will test a new way to lower increasing drug prices for patients paying for drugs under Medicare Part B.

How will biosimilars continue to affect the prescription product market in 2021?

The advent of generic and biosimilar medicines for novel treatments has helped bridge the gap in the delivery of cancer care between the United States and India, according to the study.

In studies presented this month at the European E-Congress of Rheumatology 2020, investigators revealed positive findings for the infliximab biosimilar CT-P13 (Inflectra, Remsima), which is developed by Celltrion of Incheon, Republic of Korea.

Rituximab-abbs (Truxima) is the only biosimilar to the reference product rituximab (Rituxan). 

Merck has announced the US launch of trastuzumab-dttb (Ontruzant), a biosimilar to trastuzumab (Herceptin), in both 150-mg single-dose vials and 420-mg multiple-dose vials.

Officials with the FDA have approved a 420-mg multi-dose of trastuzumab-bttb (Ontruzant, Samsung Bioepis), a biosimilar referencing trastuzumab (Herceptin).

Pfizer announced the introduction of 3 new oncology biosimilars to the US market at a substantially discounted price.

Biosimilar to Remicade

Expected U.S. launch in 2023.

Biosimilars may need more time to devleop in the market.

Biologic medicines could lower spending by $153 billion by 2023.

New changes are making it more difficult for generics and biosimilars to compete on formularies.

CD20-directed antibody indicated for several cancers and other conditions.

Biosimilar guidance provides “clarity” for drug developers.

Indicated for breast cancer, and gastric or gastroesophageal junction adenocarcinoma. 

Only new biosimilars and interchangeables will recieve four-letter suffixes.

The report by Magellan Rx Management indicates PMPM, site of service, and Medicaid prices continue to increase.