...Players Becoming Visible: A relatively large number of companies are demonstrating their intentions to enter the biosimilar market. Interestingly, branded drug developers, including Amgen, Eli Lilly, Merck and Pfizer, have already begun clinical trials for biosimilar products. Some larger generic firms, including Sandoz (Novartis) and Teva are also developing biosimilar products. Clearly, scale and expertise are influencing early entries into the space. Case-by-Case Approach: Fitch believes the experience of early users of the 351(k) pathway (biosimilar regulatory pathway) will vary depending on the biosimilar submitted. The relatively less complex, human proteins will logically enjoy the simplest, quickest and least costly approval process. More complex, monoclonal antibodies will likely face more intense scrutiny. In any case, biosimilars already marketed in Europe may receive a less onerous approval process, given their real-world safety and efficacy records. One Approval So Far: Zarxio...
