More about biosimilars 

Biosimilars – a major future market

By 2010, it is estimated that more than 50% of newly approved medicines will be biopharmaceuticals. The period beginning in 2010 will also see an increasing number of major biotechnology-based medicines coming off patent and facing generic competition.

Biosimilars, or follow-on proteins, are new versions of existing biopharmaceuticals whose patents have expired. They are produced using the same core genetic material and are approved on the basis that they are equal to the reference product in terms of both safety and efficacy. Biosimilars are large, complex molecules produced by living organisms, which are sensitive to manufacturing changes; generics are small molecules, produced by chemical synthesis, which are usually very stable. Biosimilars is an official term used by the European medical authorities; the US terminology is follow-on protein products (FOPPs).

At Sandoz, we are playing a pioneer role in the development of this exciting new field, which offers major savings to patients and healthcare systems and promises to become a major future market for companies like Sandoz.

With decades of experience in biotechnology, a global development and production network and an unrivalled reputation for quality, Sandoz is ideally placed to capture the biosimilars opportunity. Indeed, we are already at the forefront of bringing affordable high-quality biosimilars to patients once patents expire. Following the precedent-setting launch of human growth hormone Omnitrope® in both the EU and the US, we have now also marketed the first truly complex biosimilar (anemia medicine epoetin alfa) in the EU.

How are biosimilars different? 

 

  Small molecule generics Biosimilars
Product characteristics
  • Small molecules
  • Often very stable
  • Mostly without a device
  • Large, complex molecules
  • Stability requires special handling
  • Device is often a key differentiator
Production
  • Produced by chemical synthesis
  • Produced in living organisms
  • Highly sensitive to manufacturing changes
  • Often comparatively high costs
Development
  • Very limited clinical trials (often only Phase I PK/PD studies)
  • Significant R&D (i.e. cell lines)
  • Extensive clinical trials, including Phase I and Phase III studies
Regulation
  • Abbreviated registration procedures in Europe and US
  • Usually enjoy "substitutability" status
  • Regulatory pathway now defined by EMEA
  • "Comparability" status
  • No pathway yet in US under BLA
Marketing
  • No or limited detailing to physicians
  • Key role of wholesalers and payors
  • Market substitution in pharmacies
  • High price discounts
  • Detailing to (specialist) physicians required
  • Pharmacists may not substitute
  • Price discounts smaller; price sensitivity is product specific