Biologics are, mostly, large proteins derived from living organisms or cells and manufactured through a highly complex biotechnological process. Although these drugs are very efficacious, their cost is a major issue for patients and reimbursement agencies. A biosimilar, is the alternative to the original biologic, which shares highly similar, but not identical, safety, and efficacy profiles. Biosimilars may represent a more economical alternative to the costly biological agents already on the market.Since the first biologics were approved in the 80s, many of them have gone off patent and many others will expire in the coming decade. Coinciding with the expiration of exclusive rights, many biosimilars have been developed. In 2006, EMA approved the first biosimilar: Omnitrope.The manufacturing process of biologics is complex and requires a very high level of expertise. The quality of the biologic product is highly influenced by changes in the production process (different expression system, growth conditions...). The biosimilar developing companies have no access to the biologic reference expression system and thus, they need to make an exercise of reverse engineering. Biosimilars cost about $100 million to $250 million to reach the approval stage, versus around $2 million to $3 million for a generic small-molecule drug.EMA only gave general guidelines for biosimilars in 2012 and up to the date, 21 biosimilars have been approved in Europe. The number of biosimilars approved in U.S. is quite limited (3) as the FDA didn’t legislate biosimilars until 2015. These delayed guidelines, written by industry and regulatory representatives, provoked a lack of confidence towards biosimilars specially from the side of the medical professionals, who were not involved in designing these guidelines. Even given the uncertainty surrounding biosimilars, there are considerable commercial opportunities. It is easier to copy than create; biosimilars have a better chance to make it to market and are therefore less risky than branded biologics. In addition, the investment in biologics is much greater than in biosimilars, and the probability of success is lower.At Intelligent Pharma we believe that applying in silico techniques (developing prediction models based on physical and clinical properties) can optimize the development of biosimilars. Share with us your opinion!
07/12/2016 | Tags:
1 of 10