各種生物學名藥的商業策略

本報告已在2011年12月21日停止出版。

簡介

目錄

The rush to develop and market biogenerics has begun. While the United States dragged its feet drafting legislation to codify issues surrounding biogenerics, biogenerics companies have successfully brought products to several other markets around the world. Looking forward, developers of biogenerics must monitor not only the nuances of specific biologics markets but also the long-term commitment they will be required to make when developing biogenerics and the significant capital investment that will be required to achieve success. On the other side of the coin, originator companies have much to lose from the uptake of biogenerics. Second-generation products designed to extend the half-lives of biologics and to protect brand franchises have never been more important in order to fend off the challenge of a new category of drugs that will have more impact on biologic markets over the next ten years than any other single factor. Above all else, however, innovative new products are needed to expand pharmaceutical markets, not just to replace market share lost to biogeneric erosion.

• Companies developing biogenerics must gauge the likelihood that a more innovative product may supersede the originator biologic product they are targeting. In which area of U.S. and European biologics markets have innovative, modified products almost completely replaced unmodified versions?
• To date, the European market is the most complex market for erythropoiesis-stimulating proteins (ESPs) and encompasses all three types of competing ESPs (brands, biogenerics, and modified brands). Which companies have ESPs on the market in Europe, and how successful are these companies' drugs?
• Adherence to strategies that guide the development of biogenerics can optimize a company' s chances of success in today' s morphing biologics marketplace. What strategies should companies consider when developing biogenerics?
• Oncologists and endocrinologists in the United States, France, and Germany have nuanced, product-specific perspectives regarding the adoption of specific biogeneric products (including biogeneric ESPs, granulocyte G-CSF, insulin, and hGH). How robust will clinical studies of these biogeneric products need to be for a majority of these physicians to become comfortable prescribing biogeneric agents?

• Understanding the markets: contending with originator brands, second-generation branded biologics, other biogeneric entrants, and other branded biologics.
• How the process defines the product: the fundamental differences between traditional small-molecule pharmaceuticals and biologic agents; the pivotal role of companies' trade secrets; manufacturing variabilities and the Ebrex disaster; assessing therapeutic equivalence for biologic products.
• Selecting the right comparator: how selection determines the amount of preclinical and clinical studies required; legal impediments; commercial considerations.
• Establishing a manufacturing process: the role regulators play in biomanufacturing protocol; the role of development efforts and costs associated with standardizing and optimizing biologic product manufacture; the advantages of de novo manufacturing processes.
• Establishing comparability: preclinical studies; clinical development; pharmacodynamic markers and safety databases; target indications; minimum trial requirements.
• Anticipating long-term studies of immunogenicity: pharmacovigilance and postmarketing commitments.
• Pricing strategies: the role of market competition; principal drivers of biogenerics adoption; the pricing strategies of Omnitrope and Genotropin.
• Promotion strategies: nuanced, product-specific perspectives of physicians in the United States, France, and Germany.
• Outlook: the major drivers behind the push for biogenerics; requirements for success in the biogenerics market; the unique competitive environment lying ahead.

• Affymax
• Amgen
• Astellas
• Bioceuticals
• Arzneimittel
• BioPartners
• Chugai
• Dr. Reddy' s
• Dragon
• Pharmaceutical
• Eli Lilly
• Eyetech
• Pharmaceuticals
• Ferring
• Pharmaceuticals
• Fibrogen
• Genentech
• Hexal Biotech
• Forschungs
• Hospira
• Johnson & Johnson
• Medice Arzneimittel
• Putter
• Merck
• Novartis
• Novo Nordisk
• Ortho Biotech
• OSI Pharmaceuticals
• Pfizer
• Prolong
• Pharmaceuticals
• Roche
• Sandoz
• Sanofi-Aventis
• Schering-Plough
• Serono
• STADA Arzneimittel
• Takeda
• Valeant
• Pharmaceuticals
• Wockhardt
• Yamanouchi

• Abseamed
• Apidra
• Aranesp
• Binocrit
• Epoetin alfa Hexal
• Epogen
• Eprex
• Erythropoietin (approved biogeneric)
• Genotropin
• Granocyte/Neutrogin
• Grastim
• Hematide
• Humalog
• Humatrope
• Humulin N
• Humulin R
• Humulin U
• Infergen
• Infergen/Advaferon
• Intron-A
• Lantus
• Levemir
• Lucentis
• Macugen
• Maxomat
• Mircera
• NeoRecormon
• Neulasta
• Neulasta/Neupopeg
• Neupogen
• Norditropin
• Novolin N
• NovoLog/NovoRapid
• Novolon
• Nutropin
• Omnitrope
• Pegasys
• PEG-Intron
• Procrit
• Roferon-A
• Saizen
• Valtropin
• Vioxx
• Wepox
• Wosulin
• Zomacton