publication date: Feb. 6, 2015
20150206 - Feb. 6, 2015
ISSUE 5 – FEB. 6, 2015PDF

As Biosimilar GCSF Looms Over U.S. Market, Big Players Line Up for Emerging Competition

In the next few weeks, FDA will announce its decision on Novartis’s Zarxio, a granulocyte-colony stimulating factor biosimilar to Amgen’s Neupogen.

If it’s approved—and outside observers uniformly believe it will be—Zarxio will become the first biosimilar agent to enter the U.S. market. Indeed, the FDA Oncologic Drugs Advisory Committee last month unanimously gave it thumbs up.

Being the first, Zarxio will provide a case study in the pricing of these agents.

Conversation with The Cancer Letter

Conti: Don’t Count on an 80% Price Drop From the Launch of Neupogen’s Biosimilar

Introduction of biosimilar biologics will not bring about the same price drops as introduction of generic small-molecule drugs, said Rena Conti, an economist at the University of Chicago, whose work focuses on drug pricing.

With small-molecule drugs, price drops within two years of patent expiration and the introduction of generics can amount to 80 to 90 percent off the branded price.

The price drop for biologics when biosimilars enter the market will be less dramatic, in part because only a small number of companies have the ability to produce these agents, reducing the competitive pressure that drives down prices. In addition, the costs of manufacturing biosimilar agents is higher than those associated with manufacturing generic small-molecule agents.

Medicare to Begin Coverage Of CT Lung Cancer Screening

Computed tomography screening has become a benefit for Americans covered by Medicare.

The Centers for Medicare and Medicaid Services Feb. 5 published a final decision to cover screening of current and former smokers, provided they meet stringent eligibility criteria.

Beneficiaries will go through counseling, health professionals will be required to provide documentation that “shared decision-making” took place, technical criteria for screening will be met, and data will be collected. CMS has never mandated shared decision-making as a gateway to paying for a service.

Obama Proposes $1 Billion Increase for NIH in 2016

NIH would receive a $1 billion funding boost in President Barack Obama’s $4 trillion 2016 budget—a 3 percent increase—should Congress pass his proposal. 

The additional funds would bump the NIH budget to $31.3 billion, which the White House said would support greater research in cancer, Alzheimer’s and other diseases. The proposal provides $38.8 billion in discretionary funding to the Department of Health and Human Services.

The proposal also includes $135 million for NIH’s contribution to the BRAIN Initiative, a research project announced by Obama on April 2, 2013, aimed at accelerating the development and application of innovative technologies to map the human brain.

FDA Commissioner Margaret Hamburg To Step Down Next Month

FDA Commissioner Margaret Hamburg announced that she will be stepping down at the end of March 2015.

In an email to colleagues Feb. 5, Hamburg, 59, reflected on her six-year run in the top job at the agency, and called her decision to leave “not easy.”

“My tenure leading this agency has been the most rewarding of my career, and that is due in no small part to all of you,” she wrote.

Hamburg was nominated by President Barack Obama and confirmed by the Senate in 2009.

World Cancer Day

UICC: Adding $18 Billion a Year Could Drop Cancer Deaths By 30% in Poorer Countries

New data projects that an $18 billion increase in funding per year by the international community could result in a 30 percent reduction in cancer deaths in low- and middle-income countries by 2030.

On World Cancer Day 2015, held annually Feb. 4, public health experts from the Union for International Cancer Control said that millions of lives can be saved through affordable increases in the investment into cancer services throughout the world.

CVS Provided Counseling To 67,000 in Four Months After Halting Sales of Tobacco

A year after it announced its decision to stop tobacco sales, CVS Health released data that shows how its stores are working to deliver the anti-smoking message.

According to CVS, from the launch of the program on Sept. 3, 2014, through December 2014, its pharmacists counseled more than 67,000 patients filling a first prescription for a smoking cessation drug or prescription nicotine replacement therapy.

Funding Opportunity

Crowd Research Initiative Taking Proposals in Myeloma

The Myeloma Crowd Research Initiative is accepting research proposals for high-risk multiple myeloma until the end of February, through the Myeloma Crowd website. The Myeloma Crowd is a division of the CrowdCare Foundation.

In Brief

  • Candace Johnson named president and CEO of Roswell Park Cancer Institute

  • Thomas Rutherford named physician director of the Western Connecticut Health Network

  • Carolyn Compton to lead Indivumed scientific advisory board

  • Eli Lilly donates $1 million to Kenyan health care program

Drugs and Targets

  • FDA grants accelerated approval to Ibrance in metastatic breast cancer

  • FDA approves Koning Breast CT 3D scanning system

  • Yondelis granted priority review in advanced soft tissue sarcoma

  • MPDL3280A receives second breakthrough therapy designation

Copyright (c) 2020 The Cancer Letter Inc.