Biosimilars play an increasingly important role in the expanding global market for biotech medicines. To obtain regulatory approval, a biosimilar must demonstrate comparable safety and efficacy to the to the approved biological product. When bringing a biosimilar to market, a developer must meet the rigorous approval standards that apply to other pharmaceuticals, while recognizing the effects that a biosimilar’s molecular complexity may exert during development and manufacturing.
Navigating the challenges of developing a biosimilar through clinical trials while meeting regulatory guidelines requires an experienced partner. Q2 Solutions offers tailored solutions that will help you make informed decisions and shape validated outcomes for your study, from research to commercialization.
Click the download below to learn how Q2 Solutions can partner with you to provide unique bioanalytic biosimilar capabilities.