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OVERVIEW

Cost:$2000

PUBLICATION DATE:SEP 2009

UPDATED:JUL 2010

Number of Pages:42

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Analysis of US Biogenerics

A Managed Care Perspective

REPORT SUMMARY

Along with access to the clearly organized competitive information, PharmaPeek's Biogenerics Analysis Report provides valuable insights regarding the direction of the biogenerics market from 2009-2013. This report presents both various limitations to the growth of biogenerics, as well as the effect that they will have on the growth of current biologics. The information provided focuses on the opinions of payers (including managed care, employers, and patients). Featured data was gathered from pharmaceutical, payer, and key opinion leader interviews. This report was first published in September of 2009, but later updated in July of 2010.


EXECUTIVE SUMMARY

Americans spent approximately $291 billion on pharmaceuticals in 2008, of which about 16% was spent on biopharmaceuticals as opposed to small molecules. Biopharmaceuticals are more complex than small molecules and originate from a living source. Generic forms of small molecules are currently available in the US market, saving payers money; however, generic forms of biopharmaceuticals are not currently available in the US market. Further, spending on small molecules is growing at a much slower rate than biologics and thus, developing generics of biologics might be a fruitful endeavor for generic manufacturers, payers and health care reform. The cost of health care is growing at an alarming rate and health care reform has become the focal point of the current administration, therefore, potential savings offered by the availability of biogenerics, presents an attractive target for the current administration.

The approval of biogenerics into the US market has proven to be a lengthy, complicated task. This task is subject to the FDA guidelines, which would have to stipulate the years of exclusivity for a biologic before a generic can be placed on the market, the definition of biosimilarity (similarity between the innovator and the generic), as well as the testing involved (specifically clinical trials) to approve a biogeneric for the US market. Some common biologics on the market are insulins, monoclonal antibodies used in the treatment of cancer, multiple sclerosis and rheumatoid arthritis. Respondents, defined as managed care, payers and/or pharmaceutical company representatives, outlined three scenarios for potential savings as a result of availability of biogenerics, ranging from a savings of 5-30%. The impact of each scenario on the current market will be described, and a discussion between simpler and more complex biologics, such as monoclonal antibodies, will also be discussed. Further, the impact of the savings scenarios outlined in this report will also have a profound effect on the benefit design, which will also be discussed.

Ultimately, this report will strive to present various limitations to the growth of biogenerics, as well as, the effect they will have on the growth of current biologics. This report focuses on the opinions of the payers, which include managed care, employers and patients in terms of the market for biogenerics.


TABLE OF CONTENTS

  • Chapter 1: Introduction to Biogenerics
    • Current Spending on Prescription Drugs
    • Approaches to Biogenerics
    • Current Legislation in the United States and Europe
      • United States-FDA
      • Europe-EMEA
  • Chapter 2: Respondent based-Responses Regarding Biogenerics
    • Utilization of Biologics
    • Current Acquisitions to improve Biopharmaceutical Portfolio
    • Possible Savings to Payers with introduction of Biogenerics
    • Views for Expected Savings with Biogenerics
    • Possible Alteration in the Design of Benefits
    • View of FDA’s role in acceptance of Biogenerics
    • Physician’s Burden
  • Chapter 3: Latest Legislative Developments in the US
    • Legislative Implications
  • Chapter 4: Market Analysis of Selected Biologics
    • Oncology Biologics
    • Insulins
  • Chapter 5: Conclusions
    • Review and Opinions of Current Framework for Biogenerics in the US
    • Length of Exclusivity
    • Development of a Pathway for Determining “Bioequivalence”

COMPANIES DISCUSSED

  • Roche
  • Genentech
  • Amgen
  • Pfizer
  • Centocor Inc.
  • Abbott
  • Biogen Idec
  • Sanofi Aventis (Shantha Biotech)
  • Otho Biotech
  • Novo Nordisk
  • Bristol-Myer Squibb
  • ImClone Systems
  • Baxter
  • Eli Lilly
  • Genzyme
  • Elan
  • MedImmune
  • Bayer Healthcare
  • Unigene
  • Upsher-Smith
  • Halozyme Therapeutic
  • Amphatase
  • ISTA
  • Novartis (Sandoz-Novartis)
  • Merck
  • Wyeth
  • AstraZeneca
  • CAT
  • Johnson and Johnson
  • Centocor
  • Hospira
  • Staba
  • Momenta
  • Alcon
  • Takeda
  • Millennium
  • Hologic
  • Cytyc
  • Siemens
  • Dade Behring
  • Warburg Pincus
  • Bausch & Lomb
  • Eisai
  • MGI PHARMA
  • Medtronic
  • Kyphon
  • Ventana Medical Systems
  • Celgene
  • Pharmion
  • Teva
  • Dr. Reddy’s Laboratories
  • BioCon
  • Biopartners
  • Cipla
  • Glenmark
  • Intas
  • Ranbaxy
  • Stada
  • Wockhardt
  • Mylan
  • Watson
  • Mallinckrodt

DRUGS DISCUSSED

  • Avastin
  • Enbrel
  • Remicade
  • Humira
  • Rituxan
  • Herceptin
  • Lantus
  • Epogen/Procrit
  • Neulasta
  • Novolog
  • Erbitux
  • Aranesp
  • Recombinate
  • Lucentis
  • Avonex
  • ReliOn/Novolin
  • Humalog
  • PEGASYS
  • Rebif
  • Cerezyme
  • Tysabri
  • NovoSeven
  • Synagis
  • Neupogen
  • Bestaseron
  • Humulin
  • Kogenate FS
  • Omnitrope
  • Valtropin
  • Binocrit
  • Epoetin Alfa Hexal
  • Abseamed
  • Silapo
  • Retacrit
  • Filgrastrim ratiopharm
  • Tevagrastim
  • Biograstim
  • Zarzio
  • Filgastrim Hexal
  • Lovenox
  • Tykerb
  • Insugen
  • Valtropin
  • G-CSF
  • Reditus
  • Neukine
  • Erykine
  • Intalfa
  • Nugraf
  • Macrogen
  • Binocrit
  • Shanferon
  • Shankinase
  • Shanpoletin
  • EPO-Zeta
  • TevTropin
  • Wepox
  • Wosulin
  • Genotropin
  • Levemir.