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Business Strategies for Different Types of Biogenerics


Description: 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.


Contents: Executive Summary
Strategic Considerations
Stakeholder Implications
Biogenerics Are Already on Today’s Markets
Understanding the Market for Different Types of Biologics
Erythropoiesis-Stimulating Proteins
Granulocyte Colony-Stimulating Factor
Human Growth Hormone
Insulin and Insulin Analogues
Regular Insulins
Insulin Analogues
Neutral Protamine Hagedorn Insulins
Interferon Alphas
Keeping Abreast of an Evolving Regulatory Landscape
United States
Europe
Understanding How the Process Defi nes the Product
Trade Secrets
Unexpected Clinical Effects
Selecting the Right Comparator
Legal Impediments
Commercial Considerations
Establishing a Manufacturing Process
Establishing Comparability
Preclinical Studies
Clinical Development
Pharmacodynamic Markers
Safety Database
Target Indications
Minimum Clinical Trial Requirements
Anticipating Long-Term Studies of Immunogenicity
Planning a Flexible Pricing Strategy to Refl ect Changing Market Competition
Developing Effective Promotion Strategies for Physicians
Biogenerics Outlook
Appendix. Abbreviations and Defi nitions

Tables:
1. The EMEA’s General Biosimilars Guidelines as of August 2007
2. The EMEA’s Product-Specifi c Biosimilars Guidelines as of August 2007
3. The EMEA’s Recommended Pharmacodynamic Markers
4. The EMEA’s Recommended Clinical Trial Durations
5. The EMEA’s Recommended Target Indications

Figures:
1. Nine Business Strategies for Use in Developing Biogenerics
2. Current Market for Select Erythropoiesis-Stimulating Proteins (ESPs)
3. Current Market for Select Granulocyte Colony-Stimulating Factors (G-CSFs)
4. Current Market for Select Human Growth Hormones
5. Current Market for Insulin and Insulin Analogues
6. Current Market for Select Interferon Alphas
7. Minimum Clinical Trial Requirements for Biogenerics
8. Main Drivers of Biogenerics Use: U.S. Physicians


Companies Mentioned Companies Mentioned: - 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 Pütter - 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 Mentioned: - 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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