Multi-therapy Drugs: Opportunities for Generics & Biosimilars

Date: October 22, 2011
Pages: 108
Price:
US$ 1,740.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: M9FBECC5571EN
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Multi-therapy Drugs: Opportunities for Generics & Biosimilars
Targeting multiple conditions is likely to increase a drug’s potential target audience and result in large financial returns for the developing company. With annual sales counted in billions of dollars, these blockbuster drugs are undoubtedly attractive to companies developing generics and biosimilars.

The logic is simple: more indications result in a larger number of potential patients and, consequently, greater revenue opportunities. Obviously this logic only works if there is unmet clinical need and efficacy is demonstrated in each indication, so the number of drugs approved for multiple indications is relatively small. But where multiple indications are approved, annual sales can be counted in billions of dollars. The trend for developing products for multiple indications has been particularly evident in biological pharmaceuticals and has resulted in multi-billion dollar sales over a number of years. The commercial costs of developing biosimilars are great. Better, then to have the possibility of multiple revenue streams.

Use this new report to easily answer key business questions, such as:
  • What is the latest position on extrapolating biosimilar approvals to other indications, and what impact could this have on the sector?
  • How is Big Pharma’s attitude changing as the biosimilar market develops?
  • Remicade (infliximab) generated sales of US$7.9 billion in 2010 and is indicated for 7 conditions –what are they?
  • Which companies are known to be developing biosimilar versions of Pfizer/Takeda’s Enbrel (etanercept)?
  • How might new branded development in the multi-kinase sector affect the biosimilar development of Bayer’s Nexavar (sorafenib)?
  • What revenue generating lifecycle developments will offset the challenge of generic competition for Roche’s Xeloda (capecitabine)?
Assessing additional sales potential from a valuable product fit

The multi-therapy drugs included in this report realised total sales in excess of US$70 billion in 2010. It is, therefore, hardly surprising that many are being targeted by generic companies for the development of either traditional bioequivalent generics, or as targets for the next wave of biosimilars.

The top selling multi-therapy drug in 2010 was Enbrel (etanercept), with sales reported separately by Amgen, Pfizer and Takeda amounting to a total of US$7,850 million. Remicade (infliximab) was a close second, with sales reported by Johnson & Johnson and Merck & Co totalling US$7,581 million in 2010. In third place was Abbott’s Humira (adalimumab), with sales of US$6,738 million; while Roche reported global sales of Rituxan/MabThera (rituximab) worth US$6,094 million in 2010.

While the top five in terms of sales in 2010 were biologicals, a number of small molecule multi-therapy drugs have established a place among the market leaders and are worthy of attention as they will not face the same regulatory obstacles of biosimilars. These include AstraZeneca’s Seroquel franchise, with revenue of US$5,302 million; Otsuka/Bristol-Myers Squibb’s Abilify (aripiprazole) with sales reported by Otsuka amounting to US$4,266 million; and Novartis’ Glivec/Gleevec (imatinib) with sales of US$4,265 million.

Generic and biosimilar opportunities: high risk, high reward?

With annual sales counted in billions of dollars, these blockbuster drugs are undoubtedly attractive to companies developing generics and biosimilars. Competition is often fierce for bioequivalent generics of the big sellers. Consequently, companies are likely to be vying for a relatively small slice of the market. Nonetheless, when branded sales are counted in billions of dollars, companies could still make a significant return even with generic price erosion.

The market for biosimilars is inherently different to the traditional generics market. Market acceptance remains a big challenge and the take up of biosimilars in Europe to date has been relatively slow. Not only will companies need to convince healthcare providers that biosimilar drugs are as good as the originator products, they will also have to compete with the originator companies who are less likely to exit the market than if faced with a flood of bioequivalent generics.

Biosimilar approval for multiple indications: extrapolation or additional trials?

One question that has yet to be fully answered with regard to multi-therapy drugs is whether biosimilar approval for one indication will automatically lead to approval for all indications associated with the reference product.

In the EU - so often the leading player in biosimilar regulation - the current position seems a little vague. In November 2010, the EMA discussed extrapolation in its draft guideline on similar medicinal products containing monoclonal antibodies (MAbs: EMA/CHMP/BMWP/403543/2010). The guideline suggested the possibility of extrapolation of clinical efficacy and safety data to other indications of the reference MAb, based on the overall evidence of biosimilarity. However, the reality is unlikely to be simple, particularly when the reference product is approved in unrelated indications.

The final guideline has yet to be published and a year later the subject of extrapolation remains a major topic of discussion. In the meantime, companies are hedging their bets and conducting comparative studies of their biosimilar MAbs in more than one indication.

About the Author

The report has been researched and written by Espicom Senior Analyst, Karen Holmes. Karen has over 15 years pharmaceutical and healthcare market analysis experience. Her recent studies include
FOREWORD

EXECUTIVE SUMMARY

OVERVIEW

Lifecycle Development and New Indications
  Realising Additional Sales Potential
    Rituximab: Multiple Indications from Oncology to Immunology
    Sildenafil: One Active Ingredient, Two Distinctly Branded Indications
Generic and Biosimilar Opportunities
    Biosimilar Approval for Multiple Indications: Extrapolation or Additional Trials?
    US Patent Expiries

PRODUCT ANALYSIS

ANTI-METABOLITES

  Alimta (pemetrexed)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Generic Company Activity
    Market Outlook
  Xeloda (capecitabine)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
      Colorectal Cancer
      Breast Cancer
      Gastric Cancer
    Patents
    Generic Company Activity
    Market Outlook

MONOCLONAL ANTIBODIES

  Rituxan/MabThera (rituximab)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Biosimilar Activity
    Market Outlook
  Herceptin (trastuzumab)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
      Breast Cancer
      Gastric Cancer
    Patents
    Biosimilar Activity
    Market Outlook
  Erbitux (cetuximab)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Biosimilar Activity
    Market Outlook
  Avastin (bevacizumab)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Biosimilar Potential
    Market Outlook

PROTEIN KINASE INHIBITORS

  Glivec (imatinib)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Generic Company Activity
    Market Outlook
  Tarceva (erlotinib)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Generic Company Activity
    Market Outlook
  Sutent (sunitinib)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Generic Company Activity
    Market Outlook
  Nexavar (sorafenib)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Generic Company Activity
    Market Outlook

OTHER ANTINEOPLASTIC AGENTS

  Velcade (bortezomib)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Generic Company Activity
    Market Outlook

IMMUNOSUPPRESSANTS

  Enbrel (etanercept)
    Mode of Action
    Approvals
    Competition within the Marketplace
    Patents
    Biosimilar Activity
      Merck & Co
      Avesthagen
      Protalix BioTherapeutics
      Simcere
    Market Outlook
  Remicade (infliximab)
    Mode of Action
    Approvals
    Competition within the Marketplace
    Patents
    Biosimilar Activity
    Market Outlook
  Humira (adalimumab)
    Mode of Action
    Approvals
    Competition within the Marketplace
    Patents
    Biosimilar Activity
    Market Outlook
  Cimzia (certolizumab pegol)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Biosimilar Potential
    Market Outlook
  Actemra (tocilizumab)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Biosimilar Potential
    Market Outlook
  Afinitor/Zortress (everolimus)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Renal Cell Carcinoma
    Breast Cancer
    Patents
    Generic Company Activity
    Market Outlook
  Tysabri (natalizumab)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Market Outlook

NERVOUS SYSTEM

  Lyrica (pregabalin)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Generic Company Activity
    Market Outlook
  Seroquel (quetiapine)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Generic Company Activity
      Seroquel XR
      Seroquel IR
    Market Outlook
  Abilify (aripiprazole)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Generic Company Activity
    Market Outlook
  Cymbalta (duloxetine)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Generic Company Activity
    Market Outlook

OTHER

  Viagra & Revatio (sildenafil)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Generic Company Activity
    Market Outlook

SOURCES

Espicom Sources
Others

DIRECTORY

Regulators
Manufacturers

INDEX

LIST OF TABLES

Summary of Drugs and Indications
Drug Sales, 2010 (US$ Million)
Drugs by US Patent Expiry
Alimta US Patents
Tentative ANDA Approval for Pemetrexed
Alimta Sales 2009-2016 (US$ Million)
Xeloda US Patents
Xeloda Sales, 2009-2016 (SFr & US$ Million)
Rituxan/MabThera Sales, 2009-2016 (CHF & US$ Million)
Herceptin US Patents
Herceptin Sales, 2009-2016 (CHF & US$ Million)
Erbitux Sales by Company, 2009-2016 (EUR & US$ Million)
Avastin Sales by Company, 2009-2016
Glivec US Patents
Glivec/Gleevec Sales, 2009-2016 (US$ Million)
Tarceva US Patents
Tarceva Sales, 2009-2016 (SFr & US$ Million)
Product US Patents
Sutent Sales, 2009-2016 (US$ Million)
Product US Patents
Nexavar Sales, 2009-2016 (EUR & US$ Million)
Velcade US Patents
Velcade Sales by Company, 2009-2016 (US$ Million)
Enbrel US Patents
Enbrel Sales by Company, 2009-2016 (US$ Million)
Remicade US Patents
Remicade Sales by Company, 2009-2016 (US$ Million)
Humira US Patents
Humira Sales by Company, 2009-2016 (US$ Million)
Cimzia Sales, 2009-2016 (US$ Million)
Actemra/RoActemra Sales by Company, 2009-2016
Afinitor/Zortress US Patents
Afinitor/Zortress Sales, 2009-2016 (US$ Million)
Tysabri Sales by Company, 2009-2016 (US$ Million)
Lyrica US Patents
FDA Tentative ANDA Approvals for Pregabalin
Lyrica Sales, 2009-2016 (US$ Million)
Seroquel US Patents
FDA Tentative ANDA Approvals for Quetiapine XR
FDA Tentative ANDA Approvals for Quetiapine IR
Seroquel Sales, 2009-2016 (US$ Million)
Abilify US Patents
Abilify Sales by Company, 2009-2016 (? Billion & US$ Million)
Cymbalta US Patents
FDA Tentative ANDA Approvals for Duloxetine
Cymbalta Sales, 2009-2016 (US$ Million)
Viagra & Revatio US Patents
EU Marketing Authorisations for Generic Sildenafil
FDA Tentative ANDA Approvals for Sildenafil
Viagra/Revatio Sales, 2009-2016 (US$ Million)

LIST OF FIGURES

Alimta Sales Trend 2007-2016
Xeloda Sales Trend, 2007-2016
Rituxan/MabThera Sales Trend, 2007-2016
Herceptin Sales Trend, 2007-2016
Erbitux Sales Trend, 2007-2016
Avastin Sales Trend, 2007-2016
Glivec/Gleevec Sales Trend, 2007-2016
Tarceva Sales Trend, 2007-2016
Sutent Sales Trend, 2007-2016
Nexavar Sales Trend, 2007-2016
Velcade Sales Trend, 2007-2016
Enbrel Sales Trend, 2007-2016
Remicade Sales Trend, 2007-2016
Humira Sales Trend, 2007-2016
Cimzia Sales Trend, 2008-2016
Actemra/RoActemra Sales Trend, 2008-2016
Afinitor/Zortress Sales Trend, 2009-2016
Tysabri Sales Trend, 2007-2016
Lyrica Sales Trend, 2007-2016
Seroquel Sales Trend, 2007-2016
BMS Abilify Sales Trend, 2007-2016
Otsuka Abilify Sales Trend, 2007-2016
Cymbalta Sales Trend, 2007-2016
Viagra/Revatio Sales Trend, 2007-2016
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