Abstract
Introduction:
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.
Get the Answers You Need to Shape Your Strategy:
- 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?
Scope
- 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.
Mentioned in This Spectrum Report
Companies:
- 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
Products:
- 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
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