Biosimilars

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.

An update on where the field of biosimilars currently stands.

The most read articles in The American Journal of Managed Care's Evidence-Based Oncology ranged from personal narratives to healthcare policy issues that impact the broader population.

The Patient-Centered Outcomes Research Institute (PCORI) will approach biosimilar research the way it does research on anything else, but there is the added element of finding the right timing, said Joe V. Selby, MD, MPH, executive director of PCORI.

What we're reading, October 15, 2015: federal prosecutors subpoena Valeant Pharmaceuticals over how the company prices drugs, Atul Gawande, MD, makes the case for better coordinated care, and proposed biosimilar reimbursement sparks outrage.

Palliative care should enter into the discussion with patients with cancer as early as possible as it can manage symptoms from therapy or it can provide comfort to patients who cannot afford or choose to forgo therapy, said Amy Davidoff, PhD, MS. Plus, she discusses the impact biosimilars may have on therapy costs.

With 1 biosimilar already approved in the US, the FDA has finally released draft guidelines for naming these new products.

The Biosimilars Council wants CMS to hold back on Medicare Part B reimbursement for biosimilars.

A US appeals court has blocked Novartis from selling the first biosimilar to be approved in the United States.

Will Sandoz' biosimilar, first ever in the US, ever see the light of day?

While the marketing of the first biosimilar to be approved in the US market, Zarxio, has been delayed due to a court order, the FDA is providing guidance to manufacturers to help them effectively navigate the process of product development.

Sandoz's biosimilar will be sold under the trade name Zarxio but the FDA has held off on releasing a naming policy for biosimilars, giving the product a "placeholder nonproprietary name" of "filgrastim-sndz."

In a session at AMCP's 27th Annual Meeting & Expo that was so popular that attendees were being directed to an overflow room, Aimee Tharaldson, PharmD, senior clinical consultant in emerging therapeutics at Express Scripts, highlighted specialty pharmaceuticals that are currently in development and expected to come to the market in the next few years.

Trends in healthcare are driven by innovation, which is largely being driven by specialty innovation, Douglas M. Long, MBA, vice president of industry relations at IMS Health, said during the headline session "Marketplace Trends" at the Academy of Managed Care Pharmacy's 27th Annual Meeting & Expo.

The battle is being closely watched for signs that brand-name drug makers may be able to delay the introduction of biosimilars, which are cheaper versions of brand-name biologics.