Biosimilars

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.

Zarxio was approved earlier this month, the first biosimilar to be approved in the United States.

At a state-of-the-art facility in Thousand Oaks, California, drugmaker Amgen Inc. is perfecting the art of copying others, and it must work fast because copycats are already coming for Amgen's drugs.

The study by Andrew Mulcahy, a policy researcher at the RAND Corporation, found that the predicted $44 billion saving to the US healthcare system over the next decade, would depend on FDA decisions on newer biosimilar drug candidates.

Sandoz, the companies generics unit, recently submitted an application with the US FDA for approval of it's biosimilar filgrastim; it's the first-ever biosimilar application with the FDA.

With the FDA accepting an application from Sandoz for it's biosimilar filgrastim, the biosimilar landscape in the US is expected to undergo a huge turnaround.

Within a week of Sandoz applying for approval of it's biosimlar to Amgen's Neupogen, U.S. senators want the FDA to lay down guidelines on naming these drugs.

This week, a coalition of 32 major pharmacies, health insurers, unions and pension plans asked the FDA not to require distinct names for biosimilar medications, arguing that such a move would not compromise patient safety, but could undermine the savings that are expected to be generated as these medicines are introduced into the US health care system.

According to a report by Elsevier's BusinessIntelligence, UnitedHealthcare has announced that pharmacies that are participating in its Designated Specialty Pharmacy network will no longer redeem manufacturer-sponsored coupons as an offset to member cost-sharing payments for 6 specialty drugs beginning January 1, 2013.

Trade secrets may potentially be used to protect manufacturing processes for biological drugs--yet there is concern that the new law on biosimilars, the BPCIA (Biologics Price Competition and Innovation Act of 2009), and the accompanying FDA regulations, may expose trade secrets of both originators and biosimilar applicants.

In this video, Aimee Tharaldson, PharmD, Senior Clinical Consultant, Emerging Therapeutics Express Scripts, Inc, talks about the impact that biosimilar medications could potentially have on the specialty pharmacy market.

This content is brought to you by Amgen This video summarizes the complex process of creating biologics from start to finish and describes some of the unique challenges-- and tremendous effort-- involved in delivering safe and effective biologics.