Biosimilars

The FDA has already approved 4 biosimilars in the United States, but there remains a lot of uncertainty surrounding some of the legislation and regulation.

Specialty pharmacy pipelines, healthy behaviors, and regulation took the stage at the Academy of Managed Care Pharmacy (AMCP)’s 2016 Nexus conference, which was held October 3-6 in National Harbor, Maryland.

UnitedHealth has posted a presentation on its website that provides an update to its pharmacy benefits and prescription drug lists for 2017.

Pharmacy benefit managers (PBMs) and large employer organizations are taking measures to save healthcare costs in 2017, and for PBMs, formulary exclusions is a fool-proof tactic.

What we're reading, July 6, 2016: the Department of Veterans Affairs has made progress, but still has a long way to go; court upholds 6-month delay for biosimilars; and Apple promotes organ donation with iPhone app.

What we're reading, June 24, 2016: Britain's decision to leave the European Union will impact drug regulation; Supreme Court decision derails California proposal to allow illegal immigrants to buy health insurance; and lawmakers look to reduce exclusivity period for biologics.

At the annual meeting of The Community Oncology Alliance, oncologists sat through a crash course on biosimilars that was rendered by experts from the pharmaceutical industry.

The process for approving biosimilars has been moving slowly, but Aimee Tharaldson, PharmD, senior clinical consultant of emerging therapies at Express Scripts, foresees them as having the potential to lower costs for the industry and hopes the approval process will pick up speed.

The bar is set very high in terms of the biosimilar requirement definition, and physicians who are hesitant about substituting biosimilars for treatment should not be worried about the perceived differences, according to Pamela S. Becker, MD, PhD, professor of medicine in the Division of Hematology at the University of Washington School of Medicine.

Jeremy Schafer, PharmD, MBA, vice president and director of specialty solutions at Precision For Value, discussed a number of important topics regarding biosimilars, including how he expects the US will have an easier time approving biosimilars and the importance of patient education about biosimilars.

What we're reading, April 19, 2016: blood-testing laboratory Theranos is now facing a criminal investigation; biosimilars may not be cheaper than brand name biologics for some seniors; and stigma and misconceptions remain regarding palliative care.

The FDA recently approved the biosimilar infliximab and found that from an immunogenicity profile it was more or less similar, which is important for payers and providers, explained Jeremy Schafer, PharmD, MBA, vice president and director of specialty solutions at Precision For Value.

Pharmaceutical industry experts provide an overview of the highly complex biosimilar development process at The Community Oncology Conference: Innovation in Cancer Care, held in Orlando, Florida.

While these "generic" biologicals have been deemed to have the potential to create competition and result in healthcare savings-although not to the extent of generic products-technical issues with manufacturing these products have troubled drug manufacturers.

Now that 1 biosimilar has made it to market in the United States, Pamela S. Becker, MD, PhD, professor of medicine in the Division of Hematology at the University of Washington School of Medicine, expects more to follow and that, hopefully, biosimilars will help achieve cost savings for healthcare.

According to IMS Health, increased penetration and acceptance of biosimilars in Europe and in the United States can result in $110 billion in total savings to the 2 healthcare systems.

Recent analysis supports the potential importance of using biosimiliars of granulocyte colony stimulating factor to manage neutropenia affecting post-chemotherapy and post-op patients.

What we're reading, February 18, 2016: one-third of clinical trial results are never published; Sandoz challenges rule for notices of biosimilar launches; and hepatitis C combination drug could reduce treatment to just 4 weeks.

Scientists at the FDA have provided their recommendation to be submitted to an independent medical advisory panel that will decide the fate of Remsima.

What we're reading, January 8, 2016: HHS releases report with full Obamacare enrollment information for all 50 states and the District of Columbia; the expansion of the biosimilars in 2016; and promising Ebola treatment found not effective.