Biosimilars, which are new versions of innovator biopharmaceutical products that are marketed after expiration of patents, have emerged as one of the fastest growing development opportunities in the biopharmaceutical sector. In the U.S. alone, industry analysts estimate that biologics worth $80 billion are slated to go off patent by 2015.
Regulatory agencies evaluate biosimilars based on their level of similarity to, rather than the exact replication of, the innovator drug. In the U.S., recent guidance by the FDA says it will “consider the totality of the evidence” when assessing follow-on products. This approach requires sponsors to demonstrate robust chemical comparability to the innovator compound.
The need for increased analytics and the desire for compressed timelines in biosimilars development demands in particular that developers must invest early in Chemistry, Manufacturing, and Controls (CMC)-type analysis to demonstrate comparability to the reference molecule at every stage, particularly during manufacturing.
Due to the complexity of biologics, a product can only be made that is similar to the innovator drug, not identical. Basically, it’s impossible for two different manufacturers to produce two identical products even identical host expression systems, processes, and equivalent technologies are used. Therefore, we have to rely on analytics to compare the biosimilar to the innovator product on the market.
Read more at http://blog.covance.com/2013/03/key-to-biosimilars-success/