How similar is Biosimilar?
Member of Chimica Oggi / Chemistry Today’s Scientific Advisory Board
Global pharma market reached $830B in 2010; biologics accounted for $116B (14 percent) vs. biosimilar sales of $380M. By 2015, >$60B of biologics will face patent expiration. Key drivers for biosimilar adoption are 1) higher probability of success due to known mechanism of action, 2) lower developmental cost, 3) increasing healthcare cost, and 4) market demand (aging population, affordability, insurance coverage). For small molecule drugs, legislations and regulatory guidelines have been in place for over 25 years, since the Hatch-Waxman act of 1984. For biologics the picture is much more complicated, given the complexity of quaternary structure of proteins, regulatory environment, formulation / manufacturing issues as well as sales and marketing considerations.
The European Medicines Agency (EMA) published guidelines for regulatory applications in 2005. The US Congress gave the FDA the authority to approve biosimilars as part of the Patient Protection and Affordability Act signed by President Obama in March 2010. The FDA has recently issued a draft guideline for a stepwise approach to biosimilarity to a FDA-approved biologics using the abbreviate pathway established by th ...