Biosimilars: Surveying the Market Landscape -





Published: October 2010 | 75 pages 

Worldwide, the story is the same. Governments want cheaper drugs for their populations, while the number and kinds of diseases affecting them continue to evolve and grow. 

Since 1976, when Genentech became the world’s first biopharmaceutical company, treating the more devastating diseases such as genetic disorders has been taken up by biologicals, medicines that copy or closely resemble endogenous human proteins. 

And while biologicals will represent 50 percent of the industry’s top 100 products by 2014, they have drawbacks: they’re 20 times more expensive to consumers than standard drugs, and many will soon lose patent protection. 

What will fill the void? Already, several biosimilars have entered the market around the world, as regulators In the US, EU, Japan, Canada and Australia pave the way for competition between biologics and their generic cousins. 

But unlike generics, biosimilars face several significant hurdles. A lack of stakeholder confidence in generics also exists for biosimilars, which are far more complex to develop and have, in some cases, created more medical issues than they solved. 

Obtaining approval is costly and because biosimilars are extremely complex, they cannot follow the abbreviated approval process that generics enjoy. What’s more, manufacturing costs are high and distribution is complicated. Substitution is not permitted by pharmacists, yet marketing requires an approach directed to specialists. 

Yet the biosimilar industry continues to expand. And in Biosimilars: Surveying the Market Landscape, FirstWord examines exactly how it is happening. The wide-ranging and thoroughly researched report examines early entrants to the market, in addition to those shaping up to be the leaders in this still emerging industry. The report reviews all aspects of biosimilar production, from manufacturing and marketing to the regulatory landscape. It also provides a breakdown of the current EU and American markets, as well as a close look at key biopharmaceuticals, leading companies and innovators. 

The report offers insights into:  

  • The current regulatory environment worldwide 
  • The leading biosimilar drugs and the companies making the most headway 

Key features 

  • Complete overview of the current issues facing biosimilars 
  • Breakdown of the regulatory picture in the EU, United States and other markets 
  • Review of target biopharmaceutical products 
  • An up-to-date overview of leading biosimilar companies, innovator pharmaceutical firms and companies in emerging markets 

Key biopharmaceuticals covered in this report include 

  • Somatropin 
  • Epoetin 
  • Filgrastim 
  • Insulin 
  • Interferon alpha and beta 
  • Low-molecular-weight heparins 
  • Monoclonal antibodies and anti-inflammatory fusion proteins 
  • Follitropin 

Executive Summary  

Introduction  

Biosimilars are not generics  

> Manufacturing
> Safety and immunogenicity
      - Automatic substitution and naming
> Development
> Marketing
      - Market acceptance
> Patents
 

Regulatory picture  

> EU
      - Guidelines
      - Substitution
      - Data exclusivity
      - Pre-approval trials
      - Post-marketing surveillance (pharmacovigilance)
      - Extrapolation
      - Monoclonal antibodies
> USA
      - Legislation
      - Substitution/interchangeability
      - Data exclusivity
      - Extrapolation to other indications
      - Patent information exchange
      - Biological products approved as drugs
 Other markets
      - Global biosimilars strategy
 

Target biopharmaceutical products  

> Somatropin (growth hormone)
> Epoetin (erythropoietin)
> Filgrastim
> Insulin
> Interferon alfa
> Interferon beta
> Low-molecular-weight heparins
> Monoclonal antibodies and anti-inflammatory fusion proteins
      - Immunomodulators – anti-TNF antibodies
      - Cytotoxic mAbs
> Follitropin (follicle-stimulating hormone; FSH)
> Vaccines
> Enzymes
      - Imiglucerase
> Blood coagulation factors
 

Biosimilars companies  

> Generics manufacturers
> Sandoz
> Teva
> Hospira
> Stada
> Mylan
> Watson
> Actavis
> Apotex
> Other generics manufacturers
> Innovator pharmaceutical companies
> Merck & Co.
> Pfizer
> GlaxoSmithKline
> Eli Lilly
> AstraZeneca
> Companies in India and other emerging markets
> Biocon
> Dr Reddy’s
> Reliance Life Sciences
> Intas
> Wockhardt
> Ranbaxy (Daiichi Sankyo)
> Cipla
> Other markets
 

Future prospects